Zimmer, Inc.
Medical device manufacturer in Warsaw, IN.
422510(k) clearances
2PMA approvals
974recalls
Device types
- JWH Prosthesis, Knee, Patellofemorotibial… 51
- LPH Prosthesis, Hip, Semi-Constrained… 46
- LZO Prosthesis, Hip, Semi-Constrained… 34
- HRS Plate, Fixation, Bone 32
- JDI Prosthesis, Hip, Semi-Constrained… 27
- HSB Rod, Fixation, Intramedullary And Accessories 23
- MBH Prosthesis, Knee, Patello/Femorotibial… 19
- HWC Screw, Fixation, Bone 12
- KTT Appliance, Fixation, Nail/Blade/Plate… 10
- PHX Shoulder Prosthesis, Reverse Configuration 10
- HSX Prosthesis, Knee, Femorotibial… 9
- KWA Prosthesis, Hip, Semi-Constrained (Metal… 9
- KWT Prosthesis, Shoulder, Non-Constrained… 8
- JDC Prosthesis, Elbow, Constrained, Cemented 8
- KWS Prosthesis, Shoulder, Semi-Constrained… 7
- KWP Appliance, Fixation, Spinal Interlaminal 7
- KRO Prosthesis, Knee, Femorotibial… 6
- MBF Prosthesis, Shoulder, Semi-Constrained… 5
- HAW Neurological Stereotaxic Instrument 5
- KWY Prosthesis, Hip, Hemi-, Femoral… 5
510(k) clearances (latest 300)
| 510(k) | Device | Decision |
|---|---|---|
| K261683 | Augment Off-Axis Instrument SystemPHX · Special | 06/16/2026SE |
| K260831 | Z1 Hip SystemLZO · Traditional | 06/16/2026SE |
| K251840 | Zimmer® Persona® Personalized Knee SystemMBH · Traditional | 05/28/2026SE |
| K260182 | Avenir® Müller Stem; Avenir Complete Hip SystemLZO · Traditional | 04/27/2026SE |
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…MBF · Traditional | 04/13/2026SE |
| K253566 | Affixus Retrograde Femoral Nailing SystemHSB · Traditional | 03/12/2026SE |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)MBH · Traditional | 03/09/2026SE |
| K252623 | G7® Revision Acetabular SystemLPH · Traditional | 02/04/2026SE |
| K251098 | Identity Revision Humeral StemsMBF · Traditional | 08/11/2025SE |
| K251906 | Z1 Hip SystemLZO · Special | 07/18/2025SE |
| K250848 | Identity Shoulder SystemMBF · Traditional | 07/02/2025SE |
| K243724 | Persona® Revision Knee System (Persona Revision SoluTion Femoral Components)JWH · Traditional | 03/06/2025SE |
| K243907 | Affixus Tibial Nailing System - 4mm screwsHSB · Traditional | 02/12/2025SE |
| K241873 | OsseoFit Stemless Shoulder SystemPKC · Traditional | 12/11/2024SE |
| K242543 | Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)MBH · Traditional | 11/22/2024SE |
| K243247 | Persona the Personalized Knee SystemMBH · Special | 10/29/2024SE |
| K241651 | Affixus Tibial and Antegrade Femoral Nailing SystemHSB · Traditional | 09/26/2024SE |
| K240876 | Identity Shoulder SystemMBF · Traditional | 06/12/2024SE |
| K240299 | Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)MBH · Traditional | 04/26/2024SE |
| K230321 | Persona Personalized Knee SystemJWH · Special | 03/08/2023SE |
| K211047 | CoCr HeadLPH · Traditional | 01/10/2023SE |
| K221479 | Persona Personalized Knee SystemJWH · Traditional | 11/17/2022SE |
| K222566 | Zimmer Persona Personalized Knee SystemMBH · Traditional | 10/17/2022SE |
| K213856 | Identity Shoulder SystemMBF · Traditional | 09/15/2022SE |
| K212512 | G7® Vivacit-E® Freedom® Constrained LinerPBI · Traditional | 04/28/2022SE |
| K210842 | VerSys Cemented Revision/CalcarJDI · Traditional | 12/10/2021SE |
| K210829 | Persona Revision Knee System Femoral Metaphyseal ConesJWH · Traditional | 05/18/2021SE |
| K210551 | Persona Revision Knee SystemJWH · Special | 03/18/2021SE |
| K192798 | Zimmer Segmental SystemKRO · Traditional | 12/10/2020SE |
| K191449 | ZCA All-Poly Acetabular CupsJDI · Traditional | 07/16/2020SE |
| K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling IJDI · Traditional | 07/09/2020SE |
| K200814 | Affixus(R) Natural Nail(R) System Humeral NailHSB · Special | 04/28/2020SE |
| K200112 | Zimmer Hip Joint ReplacementLZO · Traditional | 04/10/2020SE |
| K200209 | Persona Personalized Knee SystemJWH · Traditional | 03/24/2020SE |
| K191735 | CPT Hip SystemJDI · Traditional | 03/20/2020SE |
| K200151 | Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial…HSX · Traditional | 03/17/2020SE |
| K192660 | Zimmer M/L Taper Hip ProsthesisLZO · Traditional | 02/28/2020SE |
| K193180 | Alliance Augmented GlenoidKWS · Traditional | 02/24/2020SE |
| K193099 | Anatomical Shoulder SystemPHX · Traditional | 01/29/2020SE |
| K193223 | Persona Personalized Knee SystemJWH · Traditional | 01/24/2020SE |
| K193050 | Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral StemLZO · Special | 12/26/2019SE |
| K192189 | Avenir Complete Hip System, Size 0 Coxa VaraLZO · Traditional | 12/18/2019SE |
| K193030 | Avenir Muller Stem, Avenir Cemented Hip StemLZO · Special | 12/06/2019SE |
| K190656 | Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsLPH · Traditional | 12/06/2019SE |
| K190660 | G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…LPH · Traditional | 12/05/2019SE |
| K192236 | Fitmore Hip StemKWY · Special | 11/05/2019SE |
| K183457 | Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadLPH · Traditional | 11/05/2019SE |
| K191814 | Alliance GlenoidKWS · Traditional | 10/23/2019SE |
| K192312 | Zimmer Natural Nail System Cephalomedullary NailsHSB · Special | 10/11/2019SE |
| K192416 | BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemLZO · Special | 10/01/2019SE |
| K192217 | NCB Plating System Distal Femur and Proximal TibiaHRS · Special | 09/13/2019SE |
| K191625 | Persona Revision Knee SystemJWH · Traditional | 09/05/2019SE |
| K192021 | NCB Polyaxial Locking Plate SystemHRS · Special | 08/22/2019SE |
| K191781 | Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis SystemLZO · Special | 08/06/2019SE |
| K191238 | Zimmer Guide Wire DevicesHSB · Traditional | 07/05/2019SE |
| K190068 | Vanguard XP Knee SystemJWH · Traditional | 06/04/2019SE |
| K182678 | Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR LabelingLPH · Traditional | 05/31/2019SE |
| K183583 | Vanguard Complete Knee SystemJWH · Traditional | 05/10/2019SE |
| K181171 | Zimmer Biomet Ceramic HeadsLZO · Traditional | 04/02/2019SE |
| K183136 | Zimmer Segmental System Proximal Femoral ComponentLZO · Special | 01/30/2019SE |
| K181307 | Zimmer Nexel Total Elbow, Connrad/Morrey Total ElbowJDC · Traditional | 01/28/2019SE |
| K181761 | Zimmer Biomet Select Ceramic HeadsLZO · Traditional | 12/26/2018SE |
| K181827 | Affixus Natural Nail System Humeral NailHSB · Traditional | 12/14/2018SE |
| K182048 | Avenir Complete Hip SystemLZO · Traditional | 12/07/2018SE |
| K181947 | Persona Revision Knee SystemJWH · Traditional | 10/25/2018SE |
| K172524 | Zimmer Persona Personalized Knee SystemMBH · Traditional | 05/17/2018SE |
| K173057 | Zimmer Knee Joint Replacement Prostheses MR LabelingJWH · Traditional | 03/29/2018SE |
| K173417 | Zimmer Persona Personalized Knee SystemMBH · Traditional | 01/30/2018SE |
| K171858 | Sidus Stem-Free ShoulderPKC · Traditional | 12/18/2017SE |
| K172767 | Zimmer Trabecular Metal Reverse Shoulder System, Mini GlenoidPHX · Traditional | 11/30/2017SE |
| K172114 | Zimmer Natural Nail SystemHSB · Special | 08/10/2017SE |
| K170711 | ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemPHX · Traditional | 06/01/2017SE |
| K170072 | Fitmore® Hip StemKWY · Special | 02/07/2017SE |
| K161620 | Anatomical Shoulder Domelock Dome centricHSD · Traditional | 11/01/2016SE |
| K161830 | Zimmer M/L Taper Hip ProsthesisLZO · Special | 10/26/2016SE |
| K161192 | Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemLZO · Special | 07/08/2016SE |
| K160085 | Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…KWS · Special | 03/08/2016SE |
| K151716 | Cable-Ready Cable Grip System: Cable-Ready Bone Plate SystemHRS · Traditional | 01/28/2016SE |
| K151848 | Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemJDQ · Traditional | 01/15/2016SE |
| K151907 | Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage…KTT · Traditional | 12/30/2015SE |
| K152755 | FastFrame External Fixation System-Ankle SpanningKTT · Traditional | 12/21/2015SE |
| K152484 | FastFrame External Fixation System - Distal RadiusKTT · Traditional | 12/04/2015SE |
| K152494 | Zimmer NexGen Complete Knee Solution Tibial and Femoral AugmentsJWH · Traditional | 11/25/2015SE |
| K152841 | Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical ScrewsHWC · Traditional | 11/24/2015SE |
| K151992 | FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System -…KTT · Traditional | 11/02/2015SE |
| K151448 | Continuum and Trilogy Integrated Taper (IT) Acetabular SystemsLPH · Traditional | 08/13/2015SE |
| K150889 | Suture Wires and Wire LoopsJDQ · Traditional | 07/01/2015SE |
| K150730 | Zimmer PSI Shoulder SystemKWT · Traditional | 06/16/2015SE |
| K143321 | ITST Intertrochanteric/Subtrochanteric Fixation SystemHSB · Traditional | 05/29/2015SE |
| K150090 | Zimmer Persona Personalized Knee SystemMBH · Traditional | 05/20/2015SE |
| K150818 | Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral…KTT · Traditional | 05/01/2015SE |
| K150626 | Rush Medullary PinsHTY · Traditional | 05/01/2015SE |
| K150501 | Zimmer Nexel Total Elbow Ulnar Cement DiverterJDC · Traditional | 04/23/2015SE |
| K143165 | Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated…HWC · Traditional | 03/31/2015SE |
| K143331 | Zimmer Plates and Screws System (ZPS) - Non-sterile ZPSHRS · Traditional | 03/04/2015SE |
| K150121 | Zimmer Periarticular Plating SystemHRS · Traditional | 02/23/2015SE |
| K150028 | Zimmer Segmental System XT ComponentsKRO · Special | 02/06/2015SE |
| K143618 | Kirschner Wires, Steinmann PinsHTY · Traditional | 02/06/2015SE |
| K142787 | Zimmer Persona Personalized Knee SystemJWH · Traditional | 12/22/2014SE |
| K143066 | Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile…HRS · Traditional | 11/28/2014SE |
| K142403 | Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…KWS · Traditional | 11/24/2014SE |
| K142836 | Zimmer Plates and Screws (ZPS), Forte ScrewsHRS · Traditional | 11/12/2014SE |
| K142579 | Zimmer Periarticular Plating SystemHRS · Traditional | 10/22/2014SE |
| K142281 | Zimmer M/Dn Intramedullary Fixation SystemHSB · Traditional | 10/22/2014SE |
| K142442 | Magna-Fx and Mini Magna-Fx Cannulated Screw Fixation SystemHWC · Traditional | 10/03/2014SE |
| K141697 | Xtrafix External Fixation System, Xtrafix Small External Fixation SystemKTT · Traditional | 09/18/2014SE |
| K141840 | Trabecular Metal Tibial Cone Broach, Trabecular Metal Coupled Tibial Cone BroachMBH · Traditional | 09/03/2014SE |
| K142166 | Total Shield Surgical;Toga(Regular, Large,X-Large);Hood; Helmet Advanced Helmet W/Led…FYA · Special | 08/28/2014SE |
| K140508 | Zimmer Plates and Screws System(Zps)- Non-Sterile Plates and ScrewsHRS · Traditional | 08/14/2014SE |
| K141734 | Zimmer Periarticular Locking SystemHRS · Traditional | 08/13/2014SE |
| K141517 | Zimmer Plates and Screws (Zps)-Non-Sterile PlatesHRS · Traditional | 08/13/2014SE |
| K133378 | Zimmer Trabecular Metal Reverse Shoulder SystemPHX · Traditional | 05/12/2014SE |
| K133737 | Zimmer(R) Persona the Personalized Kee System 14X +30MM Tapered Stem ExtensionJWH · Traditional | 02/04/2014SE |
| K131413 | Xtrafix Small External Fixation SystemKTT · Traditional | 01/28/2014SE |
| K132386 | Totalshield Surgical Helmet SystemFYA · Traditional | 12/23/2013SE |
| K133246 | Zimmer Distal Radius Plating SystemHRS · Traditional | 12/17/2013SE |
| K130810 | Zimmer Motionloc Screw for Periarticular Locking Plate SystemHWC · Traditional | 09/19/2013SE |
| K130595 | Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial NailHSB · Traditional | 09/17/2013SE |
| K131884 | Avenir Cemented Hip StemLZO · Traditional | 08/22/2013SE |
| K123553 | Zimmer A.T.S. 4000TS Automatic Tourniquet SystemKCY · Traditional | 08/09/2013SE |
| K130661 | Zimmer Trabecular Metal Reverse Shoulder SystemPHX · Traditional | 05/09/2013SE |
| K130899 | Biolox Delta Ceramic Femoral HeadsLZO · Special | 05/01/2013SE |
| K123862 | Zimmer Nexel Total ElbowJDC · Traditional | 03/12/2013SE |
| K123392 | Avenir Muller StemLZO · Traditional | 03/04/2013SE |
| K130143 | Persona Natural Tibia BaseplatesJWH · Special | 02/22/2013SE |
| K123459 | Zimmer Persona TM Personalized Knee SystemMBH · Traditional | 02/22/2013SE |
| K123918 | Motionloc Screw for NCB Polyaxial Locking Plate SystemHRS · Traditional | 02/14/2013SE |
| K122745 | Zimmer Persona the Personalized Knee SystemMBH · Traditional | 12/05/2012SE |
| K122692 | Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral StemsPHX · Traditional | 12/03/2012SE |
| K122326 | Smarttools Knee SystemOLO · Traditional | 11/30/2012SE |
| K122529 | Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceHSX · Traditional | 11/16/2012SE |
| K122765 | Persona Natural Tibia BaseplatesJWH · Traditional | 11/09/2012SE |
| K121771 | Zimmer Persona the Personalized Knee SystemMBH · Traditional | 11/07/2012SE |
| K123019 | Longevity It Highly Crosslinked Polyethyene LinersLPH · Special | 10/22/2012SE |
| K121543 | Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral StemsKWT · Traditional | 10/11/2012SE |
| K113296 | ZMR Hip System Kwz-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerLPH · Traditional | 09/14/2012SE |
| K120906 | Zimmer Trabecular Metal Total AnkleHSN · Traditional | 08/24/2012SE |
| K120715 | Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia ShortHSB · Special | 08/10/2012SE |
| K120772 | NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial…HRS · Traditional | 06/12/2012SE |
| K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersOQG · Traditional | 06/04/2012SE |
| K113369 | Zimmer Persona Knee SystemJWH · Traditional | 03/27/2012SE |
| K113556 | Wagner Cone Prosthesis SystemLZO · Special | 02/17/2012SE |
| K113718 | NCB Straight Narrow Shaft PlatesHRS · Traditional | 01/27/2012SE |
| K112885 | Zimmer Plates and Screws System Screws OnlyHWC · Traditional | 12/19/2011SE |
| K112174 | NCB Periprosthetic Femur Polyaxial Locking Plate SystemHRS · Special | 10/26/2011SE |
| K110836 | CLS Brevius Stem with Kinectiv TechnologyKWA · Traditional | 10/07/2011SE |
| K111447 | Zimmer Periarticular ScrewsHWC · Traditional | 10/05/2011SE |
| K110791 | Bigliani / Flatow (R) the Complete Shoulder SolutionKWT · Traditional | 09/02/2011SE |
| K110940 | Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal…KRO · Traditional | 07/01/2011SE |
| K111039 | Zimmer Periarticular Locking Plate SystemHRS · Special | 05/19/2011SE |
| K103662 | Continuum and Trilogy Integrated Taper (It) Acetabular Systems; Longevity It Highly…LPH · Special | 04/15/2011SE |
| K103404 | ANA0TOMICAL Shoulder TM Combined SystemKWT · Traditional | 03/15/2011SE |
| K101730 | Longevity It Highly Crosslinked Polyethylene Constrained LinersKWZ · Traditional | 12/03/2010SE |
| K101229 | Longevity It Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular…LPH · Traditional | 12/03/2010SE |
| K101622 | Zimmer Natural Nail System Retrograde Femoral NailsHSB · Traditional | 10/01/2010SE |
| K101696 | Motionloc Screw for NCB Polyaxial Locking Plating SystemHWC · Traditional | 09/10/2010SE |
| K101296 | Zimmer Segmental System Proximal Femoral Component and Small Diameter Stem ExtensionsLZO · Traditional | 07/30/2010SE |
| K093561 | Zimmer Trabecular Metal Modular Acetabular SystemLPH · Traditional | 04/28/2010SE |
| K100111 | NCB Periprosthetic Femur Polyaxial Locking Plate SystemHRS · Traditional | 04/12/2010SE |
| K093846 | Longevity It Highly Crosslinked Polyethylene Elevated LinersLZO · Special | 02/04/2010SE |
| K091003 | Zimmer MMC CupKWA · Traditional | 11/24/2009SE |
| K091973 | Metasul Taper Liners, Metasul Femoral HeadsKWA · Traditional | 11/17/2009SE |
| K091566 | Zimmer Natural Nail System Cephalomedullary NailsHSB · Traditional | 10/28/2009SE |
| K091799 | Cable Ready Cable Grip System Cable ButtonHTN · Traditional | 09/11/2009SE |
| K091508 | Zimmer Continuum Acetabular System, Zimmer Trilogy It Acetabular SystemLPH · Traditional | 09/11/2009SE |
| K090596 | Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and…HSB · Traditional | 06/30/2009SE |
| K083654 | Zimmer Universal Locking System 2.7 MM Locking Plates and Screws ( Tivanium TI-6A1-4V…HRS · Special | 02/26/2009SE |
| K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral NailsHSB · Traditional | 02/19/2009SE |
| K082527 | Zimmer Universal Locking System: 3.5 MM Locking Plates and ScrewsHRS · Traditional | 12/18/2008SE |
| K082770 | Zimmer Natural Nail System Tibial NailHSB · Traditional | 12/11/2008SE |
| K082078 | Zimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna PlatesHRS · Traditional | 11/03/2008SE |
| K081759 | NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking…HRS · Traditional | 10/16/2008SE |
| K081860 | Zimmer Segmental System Variable Stiffness Stem Extensions and Intercalary SegmentsLZO · Traditional | 09/26/2008SE |
| K073499 | Versys Epoch Fullcoat Hip Prosthesis, Model 4088 SeriesJDL · Traditional | 08/07/2008SE |
| K081007 | Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology SystemKWA · Special | 05/06/2008SE |
| K073567 | Biolox Option Ceramic Femoral Head System, Model 8777 SeriesLZO · Traditional | 03/13/2008SE |
| K073286 | Gender Solutions Natural-Knee Flex SystemJWH · Traditional | 03/07/2008SE |
| K071723 | Zimmer Porolock Mis StemKWA · Traditional | 03/07/2008SE |
| K072121 | Trabecular Metal Acetabular Revision System Cemented Contrained LinerKWZ · Traditional | 01/07/2008SE |
| K072619 | Nexgen Complete Knee Solution Lps-Flex and Knee Gender Solutions Female (GSF) Porous…MBH · Traditional | 11/21/2007SE |
| K071535 | Biolox Delta Ceramic Femoral HeadLZO · Traditional | 11/19/2007SE |
| K072281 | Nexgen Prolong All-Poly PatellaJWH · Special | 09/06/2007SE |
| K072160 | Nexgen Trabecular Metal Tibial TrayMBH · Special | 09/05/2007SE |
| K071856 | Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model(S) 7848 Series(…KWA · Special | 07/30/2007SE |
| K071718 | Trilogy Longevity Constrained LinerKWZ · Traditional | 07/13/2007SE |
| K071107 | Gender Solutions Natural-Knee Flex System; Nex Gen Complete Knee Solution Cr-Flex Gender…MBH · Traditional | 07/06/2007SE |
| K070978 | Zimmer Segmental SystemKRO · Traditional | 07/03/2007SE |
| K070695 | Zimmer Patellofemoral Joint ProsthesisKRR · Traditional | 06/07/2007SE |
| K070906 | Modificaton to: Zimmer Periarticular Locking Plates and ScrewsHWC · Special | 05/01/2007SE |
| K070292 | Durom Hip Resurfacing System, Femoral ComponentsKXA · Traditional | 04/26/2007SE |
| K063582 | Zimmer Cut Resistant Glove Liner, Xsmall, Small, Medium, Large, XlargeKGO · Traditional | 04/26/2007SE |
| K070214 | Gender Solutions Natural-Knee Flex SystemMBH · Traditional | 03/16/2007SE |
| K063251 | Zimmer M/L Taper Hip Prosthesis with Modular Neck TechnologyKWA · Traditional | 01/24/2007SE |
| K061461 | Mayo Conservative Hip Prosthesis, Model 00.65-8026-010-05LPH · Special | 12/20/2006SE |
| K063303 | Universal Locking System, 2.7MM Plates & ScrewsHRS · Special | 11/22/2006SE |
| K062228 | Zimmer Hip Computer Assisted Solutions Electromagnetic and Imageless InstrumentationHAW · Traditional | 11/08/2006SE |
| K062029 | Anatomical Shoulder Fracture SystemKWS · Traditional | 10/31/2006SE |
| K062768 | Nexgen Complete Knee Solution Legacy Posterior Stabilized Flex Fixed Bearing and…JWH · Special | 10/13/2006SE |
| K061226 | Trabecular Metal Acetabular Revision System CageLPH · Traditional | 08/02/2006SE |
| K061882 | Oxygenless Packaging Conversion of Legacy Centerpulse Standard Polyethylene DevicesJWH · Special | 08/01/2006SE |
| K060556 | Brigit Surgical DeviceHAW · Traditional | 07/31/2006SE |
| K061786 | Versys Fiber Metal Midcoat Low Head Center Hip ProsthesisLPH · Special | 07/24/2006SE |
| K061211 | NCB Plating System, Proximal Tibia PlatesHRS · Traditional | 06/14/2006SE |
| K060722 | Nexgen Complete Knee Solution Ultracongruent (Uc-Flex) Fixed Bearing Articular Surface…JWH · Traditional | 05/26/2006SE |
| K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMPHX · Special | 05/19/2006SE |
| K060040 | Zimmer M/L Taper Hip ProsthesisLPH · Special | 05/12/2006SE |
| K060370 | Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsJWH · Traditional | 04/28/2006SE |
| K060710 | Universal Locking System, 3.5MM Plates and SCREWS-4936 PLATES,4835 ScrewsHWC · Traditional | 04/26/2006SE |
| K053536 | Durom Acetabular Component and Metasul LDH Large Diameter HeadsKWA · Traditional | 03/16/2006SE |
| K052321 | Versys Epoch Fullcoat Hip ProsthesisLPH · Traditional | 02/15/2006SE |
| K053226 | Zimmer Ambulatory Pump Pain Management Systems with Fenestrated Catheter and Flow SplitterFRN · Traditional | 01/31/2006SE |
| K053274 | Anatomical Shoulder Inverse/ReversePHX · Traditional | 01/25/2006SE |
| K052425 | Zimmer Computer Assisted Solutions-Electromagnetic and Imageless Knee InstrumentationHAW · Traditional | 12/28/2005SE |
| K052906 | Zimmer Trabecular Metal Reverse Shoulder SystemPHX · Traditional | 12/19/2005SE |
| K053189 | Coonrad/Morrey Total Elbow, Model 8105 SeriesJDC · Special | 12/09/2005SE |
| K052879 | Nexgen Complete Knee Solution Mis Modular Tibial Plates and KeelsJWH · Special | 11/22/2005SE |
| K052171 | Zimmer Ambulatory Pump Pain Management System with Patient Control ModuleFRN · Traditional | 10/13/2005SE |
| K050411 | Zimmer A.T.S. 3000 Automatic Tourniquet SystemKCY · Traditional | 09/02/2005SE |
| K051516 | Trabecular Metal Revision Shell LinersJDI · Special | 07/27/2005SE |
| K051623 | Anatomical Shoulder Keeled GlenoidKWS · Special | 07/19/2005SE |
| K051098 | Periarticular Locking Plates and Screws, Model 2358 SeriesHWC · Traditional | 07/07/2005SE |
| K051491 | Trabecular Metal Primary Hip ProsthesisLPH · Special | 06/30/2005SE |
| K050105 | Nexgen Complete Knee Solution Distal Femoral SpacersJDI · Traditional | 05/17/2005SE |
| K050723 | MG II Total Knee System Stemmed Tibial Baseplate ComponentsJWH · Special | 04/20/2005SE |
| K050761 | Zimmer Trabecular Metal Humeral Stem, Sizes 6MM and 8MMKWT · Special | 04/11/2005SE |
| K043101 | Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem ExtensionsJWH · Special | 03/07/2005SE |
| K050121 | Zimmer Periarticular Locking Plate System, Model 2357 & 2359HRS · Special | 01/31/2005SE |
| K043270 | Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651, 02.02652…HSB · Traditional | 01/31/2005SE |
| K043560 | Periarticular Locking Plates and Screws, Series 2358 and 2359HRS · Special | 01/21/2005SE |
| K043227 | Periarticular Locking Plates, 2358 SeriesHRS · Special | 12/10/2004SE |
| K042761 | Wristore Distal Radius Fracture Fixator, 4600 SeriesKTT · Traditional | 11/17/2004SE |
| K042776 | Versys Hip System Beaded Midcoat Low Head Center Hip Prosthesis, Model 00-7840-XXX-XXLPH · Special | 11/04/2004SE |
| K042337 | Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic CoatingLPH · Special | 11/04/2004SE |
| K042695 | NCB Plating SystemHRS · Traditional | 10/29/2004SE |
| K042598 | Periarticular Locking Plates and Screws, 2357 and 2359 SeriesHRS · Traditional | 10/29/2004SE |
| K041100 | Nexgen Porous, Ha/Tcp, Uncemented Femoral and Tibial Baseplate ComponentsMBH · Special | 10/29/2004SE |
| K041525 | Hemovac Blood Reinfusion SystemCAC · Traditional | 10/14/2004SE |
| K042271 | Nexgen Complete Knee Solution Lps-Flex Prolong Highly Crosslinked Polyethylene Articular…JWH · Special | 10/13/2004SE |
| K041549 | Zimmer Trabecular Metal Humeral StemKWT · Traditional | 09/01/2004SE |
| K041109 | Zimmer Anatomic II Hip ProsthesisLPH · Special | 07/20/2004SE |
| K040389 | Coonrad/Morrey Elbow Cement RestrictorJDC · Traditional | 05/17/2004SE |
| K040803 | MS-30 Femoral Stem Standard and LateralLZO · Special | 04/29/2004SE |
| K040593 | Periarticular Locking Plates and Screws, 2358, 2359 SeriesHRS · Traditional | 04/12/2004SE |
| K033223 | Zimmer Ortho Guidance Systems- Hip InstrumentsHAW · Traditional | 02/18/2004SE |
| K033011 | Zimmer Ortho Guidance Systems- Knee InstrumentsHAW · Traditional | 02/12/2004SE |
| K033652 | Minimally Invasive Solutions Osteotomy Guide InstrumentGEI · Traditional | 02/04/2004SE |
| K033363 | Zimmer Unicompartmental Knee SystemHSX · Traditional | 01/16/2004SE |
| K033034 | Versys Beaded Fullcoat Calcar Hip ProsthesisLPH · Special | 11/05/2003SE |
| K032726 | Zimmer M/L Taper Hip Prosthesis, 7711 SeriesLPH · Traditional | 10/22/2003SE |
| K031061 | Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsMBH · Traditional | 10/09/2003SE |
| K032367 | Itst Intertrochanteric Subtrochanteric Intramedullary Femoral NailHSB · Special | 08/12/2003SE |
| K031572 | ZMR Hip System-Xl, Models 9921, 9922 and 9923LPH · Special | 06/24/2003SE |
| K030724 | Alumina Ceramic Femoral Heads, 28 and 32 MMLZO · Traditional | 06/03/2003SE |
| K030733 | Mayo Conservative Hip Prosthesis, Model 8026 SeriesLPH · Traditional | 05/01/2003SE |
| K030153 | Zca All-Poly Acetabular Cup, Snap-In, Model 8005-946/958-32JDI · Traditional | 04/01/2003SE |
| K030265 | CPT 12/14 Hip Prostheses, Model 00-8114-040/050-00JDI · Special | 03/04/2003SE |
| K030079 | Versys Beaded Fullcoat Bowed Revision Hip ProsthesisLPH · Special | 02/05/2003SE |
| K021826 | Trilogy Acetabular System Constrained Liner, Model 6154 SeriesKWZ · Traditional | 12/20/2002SE |
| K023211 | Nexgen Complete Knee Solution Cruciate Retaining (Cr)-Flex Femoral ComponentsJWH · Special | 10/17/2002SE |
| K021891 | Zimmer Trabecular Metal Modular Acetabular SystemLPH · Traditional | 09/05/2002SE |
| K014070 | Epoch Hip Prosthesis, Model 4075 SeriesLPH · Traditional | 07/30/2002SE |
| K013385 | Nexgen Complete Knee Solution Rotatng Hinge KneeKRO · Traditional | 01/09/2002SE |
| K013991 | Prolong Highly Crosslinked Polyethtylene Cruciate Retaining (CR) Articular Surface…JWH · Special | 12/27/2001SE |
| K010685 | Modification to Miller/Galante Precoat Unicompartmental Knee System (8 MM Articular…HSX · Special | 04/02/2001SE |
| K003910 | Nexgen Complete Knee Solution Cross-Linked Polyethylene Cruciate Retaining (CR)…JWH · Traditional | 03/19/2001SE |
| K003478 | Triology Acetabular System 46MM Large Head Liners, Model 6310LPH · Traditional | 02/05/2001SE |
| K002960 | Trilogy Acetabular System Large Head Liner, Model 6353LPH · Traditional | 12/11/2000SE |
| K001989 | Coonrad/Morrey Total Elbow. Model 32-8105 SeriesJDC · Special | 07/25/2000SE |
| K001733 | Allen Medullary Cement Plugs, Zimmer Poly Plug Intramedullary System, Model 8011 Series…JDI · Traditional | 06/20/2000SE |
| K994286 | ZMR Hip System-Porous RevisionLPH · Traditional | 03/10/2000SE |
| K992667 | ZMR Hip System-Revision TaperLPH · Traditional | 10/27/1999SE |
| K991581 | Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); Lps-Flex Fixed Bearing…JWH · Traditional | 07/30/1999SE |
| K990135 | Trilogy Acetabular System Longevity Crosslinked PolyethyleneLPH · Traditional | 07/12/1999SE |
| K972774 | Gas Plasma SterilizationJWH · Traditional | 05/05/1999SE |
| K982981 | New Zimmer Shoulder SystemKWT · Traditional | 12/17/1998SE |
| K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic CoatingLPH · Traditional | 11/12/1998SE |
| K973357 | Coonrad/Morrey Total Elbow, New Hinge PinJDC · Traditional | 03/02/1998SE |
| K973714 | Versys Hip System Beaded Hip ProsthesisLPH · Traditional | 12/24/1997SE |
| K972270 | Nexgen Complete Knee Solution Convex Inset Patella ComponentJWH · Traditional | 11/24/1997SN |
| K972690 | Zirconia Ceramic Femoral HeadLZO · Traditional | 10/15/1997SN |
| K972692 | Marchetti-Vicenzi Intramedullary Nail, HumeralHSB · Traditional | 09/19/1997SE |
| K971752 | Zirconia Ceramic Femoral Head (12/14 Taper)LZO · Traditional | 07/30/1997SE |
| K965098 | Intramedullary Nail SystemHSB · Traditional | 02/28/1997SE |
| K964769 | Versys Hip System--Fiber Metal Taper Hip ProsthesisLPH · Traditional | 02/13/1997SE |
| K963148 | Nexgen Complete Knee SolutionJWH · Traditional | 02/13/1997SE |
| K963109 | Heritage Hip SystemJDI · Traditional | 01/09/1997SE |
| K963431 | Polyester Pil Wrist/Ankle Restraint/Wrist Restraint Universal/Soft Flannel Wrist/Ankle…FMQ · Traditional | 11/06/1996SE |
| K961378 | Delta Hip ProsthesisLWJ · Traditional | 10/08/1996SE |
| K955877 | Zimmer Zirconia Ceramic Femoral HeadLZO · Traditional | 10/08/1996SN |
| K962561 | Supracondylar Intramedullary NailHSB · Traditional | 09/25/1996SE |
| K962397 | Statak Soft Tissue Attachment DeviceMBI · Traditional | 08/27/1996SE |
| K962196 | Nexgen Knee Prosthesis & Legacy Knee Prosthesis W/Co-Nidium Surface Hardening ProcessJWH · Traditional | 08/23/1996SE |
| K961789 | Resorbable Soft Tissue Attachment DeviceMAI · Traditional | 08/01/1996SE |
| K960278 | Cobalt-Chromium-Molybdenum (Co-Cr-Mo) Alloy Femoral Heads W/Co-Nidium Surface TreatmentJDI · Traditional | 07/25/1996SE |
| K960658 | Collarless Polished Taper Hip ProsthesisJDI · Traditional | 07/16/1996SE |
| K960279 | Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral…JWH · Traditional | 04/26/1996SE |
| K951185 | Nexgen Complete Knee Solution 9MM Articular SurfaceJWH · Traditional | 03/15/1996SE |
| K955473 | Gamma SystemJDI · Traditional | 02/16/1996SE |
| K952776 | Lfic or Fetto HipLWJ · Traditional | 02/14/1996SE |
| K955780 | Rigidyne a External Fixation SystemJDW · Traditional | 02/09/1996SE |
PMA approvals
Recalls (latest 200)
| Recall | Product | Initiated |
|---|---|---|
| Z-2531-2026 Class II | Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number:…Five complaints have been received identifying issues where the plastic guides were catching during reaming… | 05/20/2026Open, Classified |
| Z-2530-2026 Class II | Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number:…Five complaints have been received identifying issues where the plastic guides were catching during reaming… | 05/20/2026Open, Classified |
| Z-2529-2026 Class II | Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide…Five complaints have been received identifying issues where the plastic guides were catching during reaming… | 05/20/2026Open, Classified |
| Z-2528-2026 Class II | Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide…Five complaints have been received identifying issues where the plastic guides were catching during reaming… | 05/20/2026Open, Classified |
| Z-2527-2026 Class II | Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide…Five complaints have been received identifying issues where the plastic guides were catching during reaming… | 05/20/2026Open, Classified |
| Z-2578-2026 Class II | Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral…Firm received a complaint with no clinical impact in which a posterior augment was found within the distal… | 05/11/2026Open, Classified |
| Z-1946-2026 Class II | Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula…Ten complaints have been received identifying issues at the time of use related to the package seal… | 03/30/2026Open, Classified |
| Z-0983-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0982-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0981-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0980-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0979-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0978-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0977-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0976-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0975-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0974-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0973-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0972-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0971-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0970-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0969-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0968-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0967-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0419-2026 Class II | Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm…Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing… | 09/26/2025Open, Classified |
| Z-0418-2026 Class II | Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm…Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing… | 09/26/2025Open, Classified |
| Z-1649-2025 Class II | Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203…The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm… | 03/24/2025Open, Classified |
| Z-1648-2025 Class II | Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202…The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm… | 03/24/2025Open, Classified |
| Z-1647-2025 Class II | Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201…The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm… | 03/24/2025Open, Classified |
| Z-1646-2025 Class II | Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number…The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm… | 03/24/2025Open, Classified |
| Z-1645-2025 Class II | Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number…The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm… | 03/24/2025Open, Classified |
| Z-1433-2025 Class II | NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained…The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the… | 02/27/2025Open, Classified |
| Z-1329-2025 Class II | Z1 Femoral Hip System, Product Number 611777612There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip. | 02/12/2025Open, Classified |
| Z-1039-2025 Class II | NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10…It was identified internally that two commingle events occurred where the metal support post within the… | 01/06/2025Open, Classified |
| Z-1038-2025 Class II | NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14…It was identified internally that two commingle events occurred where the metal support post within the… | 01/06/2025Open, Classified |
| Z-0285-2025 Class II | Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally…A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178" difference in the end of… | 09/17/2024Open, Classified |
| Z-3133-2024 Class II | Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip…Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve… | 08/08/2024Open, Classified |
| Z-3132-2024 Class II | Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip…Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve… | 08/08/2024Open, Classified |
| Z-2450-2024 Class II | CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip…Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is… | 07/02/2024Open, Classified |
| Z-1608-2024 Class II | NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen…Out of specification violation of devices that results in a gap existing within the fixture that presses the… | 03/28/2024Open, Classified |
| Z-1729-2024 Class II | ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | 03/20/2024Open, Classified |
| Z-1728-2024 Class II | ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | 03/20/2024Open, Classified |
| Z-1727-2024 Class II | ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | 03/20/2024Open, Classified |
| Z-1726-2024 Class II | ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | 03/20/2024Open, Classified |
| Z-1725-2024 Class II | ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indicated for…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | 03/20/2024Open, Classified |
| Z-1724-2024 Class II | ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | 03/20/2024Open, Classified |
| Z-1723-2024 Class II | ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | 03/20/2024Open, Classified |
| Z-1722-2024 Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | 03/20/2024Open, Classified |
| Z-1721-2024 Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 16…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | 03/20/2024Open, Classified |
| Z-1720-2024 Class II | ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated for…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | 03/20/2024Open, Classified |
| Z-1719-2024 Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 12…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | 03/20/2024Open, Classified |
| Z-1718-2024 Class II | ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 10…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | 03/20/2024Open, Classified |
| Z-1717-2024 Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 8…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | 03/20/2024Open, Classified |
| Z-1716-2024 Class II | ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | 03/20/2024Open, Classified |
| Z-1715-2024 Class II | ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated for…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | 03/20/2024Open, Classified |
| Z-1714-2024 Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 16…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | 03/20/2024Open, Classified |
| Z-1713-2024 Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 12…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | 03/20/2024Open, Classified |
| Z-1712-2024 Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 10…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | 03/20/2024Open, Classified |
| Z-1711-2024 Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 8…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | 03/20/2024Open, Classified |
| Z-1710-2024 Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 6…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | 03/20/2024Open, Classified |
| Z-1709-2024 Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | 03/20/2024Open, Classified |
| Z-2519-2023 Class II | M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number…The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice… | 07/26/2023Open, Classified |
| Z-2254-2023 Class II | Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm…Thread form issue of the locking holes in that the locking screws would not properly mate with the plate.… | 06/27/2023Open, Classified |
| Z-2092-2023 Class II | NexGen Precoat Stemmed Tibial Plate Size 5Device outer packaging was incorrectly labeled. | 05/19/2023Terminated |
| Z-1294-2023 Class II | CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head…Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head… | 02/27/2023Open, Classified |
| Z-1098-2023 Class II | Identity Shoulder System Resection Planer 35mm Resection PlanerTwo planers were found to be unusable during sawbones shoulder training. | 12/07/2022Open, Classified |
| Z-0471-2023 Class II | NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial… | 12/06/2022Open, Classified |
| Z-0470-2023 Class II | NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial… | 12/06/2022Open, Classified |
| Z-0469-2023 Class II | NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial… | 12/06/2022Open, Classified |
| Z-0468-2023 Class II | NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial… | 12/06/2022Open, Classified |
| Z-0467-2023 Class II | NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial… | 12/06/2022Open, Classified |
| Z-0466-2023 Class II | NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial… | 12/06/2022Open, Classified |
| Z-0007-2023 Class II | G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E)…The outer sterile package cavity has a corner wall thickness that is below the specification. The thin… | 08/25/2022Open, Classified |
| Z-1793-2021 Class II | Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left…Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125… | 05/07/2021Terminated |
| Z-1792-2021 Class II | Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left…Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125… | 05/07/2021Terminated |
| Z-2762-2019 Class II | Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant…Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant… | 08/21/2019Terminated |
| Z-1488-2019 Class II | CBS high, countersink, cannulated, AO, Item Number ST503004542An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1487-2019 Class II | CBS micro, countersink, cannulated, AO, Item Number ST503004541An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1486-2019 Class II | Drill, contra-angle, 1.5x85mm, Item Number ST502015706An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1485-2019 Class II | Drill, 3.2x145mm, AO, Item Number ST502015650An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1484-2019 Class II | Drill, cannulated, 4x90mm, round shaft, Item Number ST502015640An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1483-2019 Class II | Drill, cannulated, 3.5x90mm, round shaft, Item Number ST502015635An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1482-2019 Class II | Drill, cannulated, 3x90mm, AO, Item Number ST502015631An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1481-2019 Class II | Drill, cannulated, 3x90mm, round shaft, Item Number ST502015630An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1480-2019 Class II | Drill, cannulated, 2.8x120mm, AO, Item Number ST502015628An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1479-2019 Class II | Drill, cannulated, 2x95mm, AO, Item Number ST502015623An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1478-2019 Class II | Drill, cannulated, 2.5x95mm, AO, Item Number ST502015621An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1477-2019 Class II | Drill, cannulated, 2.5x95mm, round shaft, Item Number ST502015620An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1476-2019 Class II | Drill, cannulated, 2x95mm, round shaft, Item Number ST502015619An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1475-2019 Class II | Drill, cannulated, 4x150mm, AO, Item Number ST502015403An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1474-2019 Class II | Drill, cannulated, 4x120mm, AO, Item Number ST502015402An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1473-2019 Class II | Drill, 2.7x125mm, AO , Item Number ST502015217An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1472-2019 Class II | Drill for 3.5mm screw, 2.5x120mm, AO, Item Number ST502015216An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1471-2019 Class II | Drill for 2.7mm screw, 2x120mm, AO, Item Number ST502015212An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1470-2019 Class II | Drill for 2.7mm screw, 2x100mm, AO, Item Number ST502015208An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1469-2019 Class II | Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number ST502015207An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1468-2019 Class II | Drill for 2.7mm screw, 20mm stop, 2x105mm, Stryker, Item Number ST502015206An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1467-2019 Class II | V-TEK", Micro-countersink, AO , Item Number ST28.66.113An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1466-2019 Class II | V-TEK", standard-countersink, cannulated, AO, Item Number ST28.66.111An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1465-2019 Class II | V-TEK", Micro-countersink, AO, Item Number 28.66.113An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1464-2019 Class II | V-TEK", micro-countersink, round shaft, Item Number 28.66.112An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1463-2019 Class II | V-TEK", standard-countersink, cannulated, AO, Item Number 28.66.111An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1462-2019 Class II | V-TEK", standard-countersink, cannulated, round shaft, Item Number 28.66.110An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1461-2019 Class II | CBS high, countersink, cannulated, AO, Item Number 503004542An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1460-2019 Class II | CBS micro, countersink, cannulated, AO, Item Number 503004541An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1459-2019 Class II | CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1458-2019 Class II | CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1457-2019 Class II | CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1456-2019 Class II | CBS high, countersink, cannulated, round-shaft, Item Number 503004342An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1455-2019 Class II | CBS micro, countersink, cannulated, round-shaft, Item Number 503004341An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1454-2019 Class II | MaxiCan 4.5 countersink, cannulated, AO, Item Number 503004177An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1453-2019 Class II | CBS 7.5 tap, cannulated, AO, Item Number 503002041An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1452-2019 Class II | Drill, contra-angle, 1.5x85mm, Item Number 502015706An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1451-2019 Class II | Drill, 3.2x145mm, AO, Item Number 502015650An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1450-2019 Class II | Drill, cannulated, 4x90mm, round shaft, Item Number 502015640An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1449-2019 Class II | V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, AO, Item Number 502015638An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1448-2019 Class II | V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 502015637An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1447-2019 Class II | V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, AO, Item Number 502015636An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1446-2019 Class II | Drill, cannulated, 3.5x90mm, round shaft, Item Number 502015635An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1445-2019 Class II | V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, contra-angle, Item Number 502015634An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1444-2019 Class II | Drill, cannulated, 3x90mm, AO, Item Number 502015631An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1443-2019 Class II | Drill, cannulated, 3x90mm, round shaft, Item Number 502015630An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1442-2019 Class II | Drill, cannulated, 2.8x150mm, AO, Item Number 502015629An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1441-2019 Class II | Drill, cannulated, 2.8x120mm, AO, Item Number 502015628An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1440-2019 Class II | Drill, cannulated, 2x95mm, AO, Item Number 502015623An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1439-2019 Class II | Drill, cannulated, 2.5x95mm, AO, Item Number 502015621An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1438-2019 Class II | Drill, cannulated, 2.5x95mm, round shaft, Item Number 502015620An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1437-2019 Class II | Drill, cannulated, 2x95mm, round shaft, Item Number 502015619An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1436-2019 Class II | Drill, cannulated, 4x150mm, AO, Item Number 502015403An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1435-2019 Class II | Drill, cannulated, 4x120mm, AO, Item Number 502015402An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1434-2019 Class II | Drill for 3.5mm screw, 2.5x125mm, stryker, Item Number 502015218An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1433-2019 Class II | Drill, 2.7x125mm, AO, Item Number 502015217An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1432-2019 Class II | Drill for 3.5mm screw, 2.5x120mm, AO, Item Number 502015216An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1431-2019 Class II | Osteofresh arthrodesis drill, 2x70mm, center tip, AO, 10mm stop, Item Number 502015213An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1430-2019 Class II | Drill for 2.7mm screw, 2x120mm, AO, Item Number 502015212An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1429-2019 Class II | Drill for 2.7mm screw, 2x125mm, Stryker, Item Number 502015211An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1428-2019 Class II | Drill for 2.7mm screw, 2x100mm, AO, Item Number 502015208An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1427-2019 Class II | Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number 502015207An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1426-2019 Class II | Drill for 2.7mm screw, 20mm stop, 2x105mm, Stryker, Item Number 502015206An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1425-2019 Class II | Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015146An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1424-2019 Class II | Drill, 26mm stop, 1.4x94mm, stryker, Item Number 502015145An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1423-2019 Class II | Drill, 2.5x135mm, AO, Item Number 502015142An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1422-2019 Class II | Drill, 2.5x87mm, AO, Item Number 502015137An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1421-2019 Class II | Drill, 2.5x94mm, Stryker, Item Number 502015136An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1420-2019 Class II | Drill, 19mm stop, 1.9x87mm, AO, Item Number 502015131An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1419-2019 Class II | Drill, 26mm stop, 1.9x94mm, Stryker, Item Number 502015130An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1418-2019 Class II | Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015124An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1417-2019 Class II | Drill, 26mm stop, 1.4x94mm, Stryker, Item Number 502015120An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1416-2019 Class II | Drill, 15mm stop, 1x76mm, AO , Item Number 502015115An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1415-2019 Class II | Drill, 15mm stop, 1x83mm, Stryker, Item Number 502015114An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1414-2019 Class II | Drill Sys2.7, 2x103mm, AO, Item Number 502015107An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-1413-2019 Class II | Drill Sys 2.7, 2x105mm, stryker, Item Number 502015106An investigation identified that the products were possibly manufactured from a different material than… | 04/08/2019Terminated |
| Z-0644-2019 Class II | Avenir Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 -…Mislabeled Labeled Avenir Mller Stem size 1, the stem inside the packaging is an Avenir Mller Stem size 2 . | 10/31/2018Terminated |
| Z-1360-2018 Class II | Normed Charcot Osteotome Chisel (Various sizes)Product may contain a gap between the handle and metal chisel which can lead to failure to properly… | 03/15/2018Terminated |
| Z-1525-2018 Class II | Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI:…A potential commingle that could result in the product in the package not matching the product on the outer… | 02/28/2018Terminated |
| Z-1524-2018 Class II | Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01)…A potential commingle that could result in the product in the package not matching the product on the outer… | 02/28/2018Terminated |
| Z-2111-2017 Class II | Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS…the devices used a different raw material to produce two countersink products which has higher hardness and… | 05/11/2017Terminated |
| Z-2292-2016 Class II | Avenir Mller Stem 4 Standard Avenir Mller Stem 6 Lateral Hip joint metal/ceramic/polymer…Product mix-up. The Avenir Mller Stem 6 lateral uncemented might be placed in the packaging of the Avenir… | 06/30/2016Terminated |
| Z-2324-2016 Class II | V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill holes into…Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential… | 06/27/2016Terminated |
| Z-2323-2016 Class II | V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill holes into…Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential… | 06/27/2016Terminated |
| Z-2322-2016 Class II | TWIST D 28X150MM CBS 45 Cann 14 MM AO; The twist drill is used to drill holes into…Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential… | 06/27/2016Terminated |
| Z-2321-2016 Class II | TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill holes into…Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential… | 06/27/2016Terminated |
| Z-2003-2016 Class II | Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System…In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS… | 05/17/2016Terminated |
| Z-0411-2016 Class II | Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee…Complaints that the ratchet teeth of the tube are not latching onto the rod. | 11/24/2015Terminated |
| Z-0410-2016 Class II | Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona…Complaints that the ratchet teeth of the tube are not latching onto the rod. | 11/24/2015Terminated |
| Z-0453-2016 Class II | Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger…The firm identified a malfunction which made it possible for a handpiece to start by itself when the power… | 11/10/2015Terminated |
| Z-0452-2016 Class II | Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger…The firm identified a malfunction which made it possible for a handpiece to start by itself when the power… | 11/10/2015Terminated |
| Z-0119-2016 Class II | Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System…In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged outer tray… | 09/03/2015Terminated |
| Z-2820-2015 Class II | Zimmer Guide Wires for orthopedic procedures.Product labeling of these sterile guide wires (external carton label and patient record label) states a… | 08/27/2015Terminated |
| Z-0027-2016 Class II | Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are…It was found through review of open Complaints and stock investigations that a single lot of Zimmer… | 08/11/2015Terminated |
| Z-2060-2015 Class II | ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fatigue of… | 06/17/2015Terminated |
| Z-1699-2015 Class I | M/L Taper with Kinectiv Technology. prosthesis, hip, semi-constrained (metal uncemented…Zimmer is initiating a voluntary recall of 64 lots (752 implants total) of M/L Taper with Kinectiv femoral… | 05/18/2015Terminated |
| Z-1696-2015 Class II | PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical…Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the… | 04/30/2015Terminated |
| Z-1694-2015 Class II | Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System…The entire scope of 4.5mm Cortical Screws listed as compatible with the M/DN system is not compatible with… | 04/29/2015Terminated |
| Z-1575-2015 Class II | NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be…The affected lot is being recalled because it was packaged without the locking screw. The locking screw… | 04/02/2015Terminated |
| Z-1523-2015 Class II | Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint…Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due… | 03/18/2015Terminated |
| Z-1360-2015 Class II | Brand Name: Persona Anterior Referencing Sizer with Locking Boom The Persona Anterior…Zimmer, Inc is voluntarily recalling 22 lots of Persona Anterior Referencing Sizer with Locking Boom, part… | 03/10/2015Terminated |
| Z-1219-2015 Class II | Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis…PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating. | 02/05/2015Terminated |
| Z-1266-2015 Class II | Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee…An increase in complaints of loosening and radiolucent lines. | 01/28/2015Terminated |
| Z-1136-2015 Class II | Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient…Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may… | 12/17/2014Terminated |
| Z-1135-2105 Class II | CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally…Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may… | 12/17/2014Terminated |
| Z-1134-2015 Class II | Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction…Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may… | 12/17/2014Terminated |
| Z-1133-2015 Class II | Metasul Femoral Head - A modular head component is used in conjunction with a femoral…Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may… | 12/17/2014Terminated |
| Z-1132-2015 Class II | CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem…Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may… | 12/17/2014Terminated |
| Z-1052-2015 Class II | Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog…Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of sonic… | 12/11/2014Terminated |
| Z-0900-2015 Class II | Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a…Samples of product from Supplier lot 14D0809 and 14D0808 showed little adhesive transfer between the Tyvek… | 12/08/2014Terminated |
| Z-0853-2015 Class II | Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach…The affected lot was supplied by contract manufacturer and are potentially subject to disassociation of the… | 12/04/2014Terminated |
| Z-1042-2015 Class II | Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical…Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x 3.5mm in… | 11/25/2014Terminated |
| Z-0424-2015 Class II | Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor…To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial… | 10/14/2014Terminated |
| Z-0423-2015 Class II | Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in…To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial… | 10/14/2014Terminated |
| Z-0198-2015 Class II | Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for…Cleaning process validation failure. | 10/09/2014Terminated |
| Z-0123-2015 Class II | The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for…Affected product did not undergo heat treatment hardening step leading to the potential for deformation of… | 10/07/2014Terminated |
| Z-1948-2015 Class II | Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in…Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity.… | 10/02/2014Terminated |
| Z-0094-2015 Class II | Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm…The affected products are missing polar boss threads. | 10/01/2014Terminated |
| Z-2737-2014 Class II | Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2.…The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone… | 09/09/2014Terminated |
| Z-2580-2014 Class II | PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size…Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary… | 08/07/2014Terminated |
| Z-2579-2014 Class II | PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with…Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary… | 08/07/2014Terminated |
| Z-2578-2014 Class II | PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the…Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary… | 08/07/2014Terminated |
| Z-2577-2014 Class II | PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the…Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary… | 08/07/2014Terminated |
| Z-2576-2014 Class II | PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular…Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary… | 08/07/2014Terminated |