Biomet, Inc.
Medical device manufacturer in Warsaw, IN.
445510(k) clearances
1PMA approvals
521recalls
Device types
- JDI Prosthesis, Hip, Semi-Constrained… 51
- LPH Prosthesis, Hip, Semi-Constrained… 44
- JWH Prosthesis, Knee, Patellofemorotibial… 40
- HWC Screw, Fixation, Bone 24
- LZO Prosthesis, Hip, Semi-Constrained… 21
- HRS Plate, Fixation, Bone 21
- KWA Prosthesis, Hip, Semi-Constrained (Metal… 11
- KWT Prosthesis, Shoulder, Non-Constrained… 11
- MBI Fastener, Fixation, Nondegradable, Soft… 10
- HRY Prosthesis, Knee, Femorotibial… 10
- KRO Prosthesis, Knee, Femorotibial… 9
- HSB Rod, Fixation, Intramedullary And Accessories 8
- MBB Bone Cement, Antibiotic 7
- MBH Prosthesis, Knee, Patello/Femorotibial… 7
- JDG Prosthesis, Hip, Femoral Component… 7
- LOD Bone Cement 7
- JDC Prosthesis, Elbow, Constrained, Cemented 7
- KWL Prosthesis, Hip, Hemi-, Femoral, Metal 6
- HTY Pin, Fixation, Smooth 5
- MBF Prosthesis, Shoulder, Semi-Constrained… 5
510(k) clearances (latest 300)
| 510(k) | Device | Decision |
|---|---|---|
| K253434 | OSSTM Orthopedic Salvage SystemJDI · Traditional | 07/01/2026SE |
| K251270 | Taperloc® Complete Hip StemLPH · Traditional | 05/19/2026SE |
| K241014 | Biomet Kirschner Wires (K-Wires)HTY · Traditional | 05/22/2024SE |
| K222760 | StageOne Select Hip Cement Spacer MoldsMBB · Traditional | 12/28/2022SE |
| K221968 | StageOne Shoulder Cement Spacer MoldsMBB · Traditional | 09/15/2022SE |
| K213287 | StageOne Knee Cement Spacer MoldsMBB · Traditional | 09/02/2022SE |
| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveJDG · Traditional | 02/07/2022SE |
| K212435 | Comprehensive Humeral Fracture Positioning SleevesKWS · Traditional | 12/10/2021SE |
| K210192 | A.L.P.S. Clavicle Plating SystemHRS · Special | 02/19/2021SE |
| K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…MBI · Traditional | 11/10/2020SE |
| K193546 | Distal CentralizersJDG · Traditional | 09/25/2020SE |
| K193373 | Comprehensive® Reverse ShoulderPHX · Traditional | 04/15/2020SE |
| K193402 | ALLthread PEEK Suture AnchorMBI · Traditional | 03/05/2020SE |
| K193451 | Titanium Interference ScrewsHWC · Traditional | 02/24/2020SE |
| K193533 | WIN Flexible Nail SystemJDS · Traditional | 02/20/2020SE |
| K192942 | ALLthread Titanium Suture AnchorMBI · Traditional | 01/16/2020SE |
| K193092 | TunneLoc Tibial Fixation DeviceMBI · Traditional | 01/02/2020SE |
| K191459 | JuggerStitch Meniscal Repair DeviceMBI · Traditional | 09/13/2019SE |
| K190035 | Biomet Headless Compression and Twist-Off ScrewsHWC · Special | 02/07/2019SE |
| K183553 | Compress and Mini Compress Anti-Rotation SpindlesMBF · Traditional | 01/22/2019SE |
| K183162 | Affixus Hip Fracture NailHSB · Special | 12/14/2018SE |
| K173767 | A. L. P. S. Clavicle Plating SystemHRS · Traditional | 04/06/2018SE |
| K173826 | THP Hip Fracture Plating SystemJDO · Traditional | 02/07/2018SE |
| K173278 | ToggleLoc SystemMBI · Traditional | 01/05/2018SE |
| K172408 | Biomet Bone Cement RLOD · Traditional | 10/05/2017SE |
| K171540 | Refobacin Bone Cement RLOD · Traditional | 08/30/2017SE |
| K171054 | Biomet Knee Joint Replacement ProsthesesJWH · Traditional | 07/28/2017SE |
| K162559 | Move Forward 3D Motion Simulation ServiceLLZ · Traditional | 03/31/2017SE |
| K161273 | StageOne Disposable Cement Spacer Molds for Temporary Knee ProsthesisMBB · Traditional | 01/25/2017SE |
| K161592 | Persona Partial Knee SystemHSX · Traditional | 11/03/2016SE |
| K162424 | Ulna Plating SystemHRS · Traditional | 10/12/2016SE |
| K161166 | StageOne Select Cement Spacer Molds for Temporary Hip ReplacementMBB · Traditional | 09/08/2016SE |
| K160071 | StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisMBB · Traditional | 06/16/2016SE |
| K161190 | G7 Dual Mobility System, Active Articulation SystemLPH · Special | 05/26/2016SE |
| K153657 | Vanguard XP Knee SystemMBH · Traditional | 05/10/2016SE |
| K160058 | Biomet Variable Pitch Compression Screw SystemHWC · Traditional | 03/09/2016SE |
| K152621 | OSS/Arcos IM Total Femur RodJDI · Special | 10/14/2015SE |
| K151603 | Arcos One-piece Femoral Revision SystemLPH · Traditional | 10/06/2015SE |
| K150850 | Refobacin Bone Cement RMBB · Traditional | 07/16/2015SE |
| K150867 | Affixus Tibial Nailing SystemHSB · Traditional | 06/10/2015SE |
| K150522 | G7 Dual Mobility SystemLPH · Traditional | 05/01/2015SE |
| K150503 | Echo Bi-Metric Microplasty Line ExtensionLPH · Special | 03/25/2015SE |
| K143192 | Vanguard 360 Revision Knee SystemJWH · Traditional | 02/12/2015SE |
| K142882 | G7 Freedom and Offset Liners, Freedom Head, Size 32LPH · Traditional | 02/10/2015SE |
| K143543 | Prelude PF PatellaeKRR · Traditional | 01/30/2015SE |
| K142933 | Biomet Tibial traysJWH · Traditional | 12/23/2014SE |
| K143009 | Echo Bi-Metric Microplasty Hip SystemLPH · Traditional | 12/18/2014SE |
| K140669 | G7 Osseoti Acetublar ShellsLPH · Traditional | 12/11/2014SE |
| K141407 | Vanguard XP Femoral Component(Gen Ii)/Vanguard XP Femoral TrialMBH · Traditional | 10/27/2014SE |
| K141331 | Biomet Orthopaedic Salvage System (Oss)JDI · Traditional | 10/27/2014SE |
| K142295 | Sirius Femoral Stem, Size 30AJDI · Special | 09/15/2014SE |
| K141762 | Perfuse Percutaneous Decompression SystemFMF · Traditional | 08/27/2014SE |
| K141653 | Biolox Delta Ceramic Option HeadsLZO · Traditional | 08/18/2014SE |
| K140883 | Vanguard 360 Osseoti Tibial Sleeve AugmentMBH · Traditional | 07/30/2014SE |
| K140902 | E1 Series a Patellae, Standard 3-PEG, E1 Series a Patellae, Thin 3-PEG, E1 Series…JWH · Traditional | 07/03/2014SE |
| K140891 | Biomet Cannulated Screw SystemHWC · Traditional | 06/03/2014SE |
| K140622 | DVR Dorsal Plate, DVR Lateral Plate, DVR Ulna PlateHRS · Traditional | 05/13/2014SE |
| K140625 | Orthosorb LSOVZ · Traditional | 04/18/2014SE |
| K140018 | TSP Hip Fracture Plating SystemJDO · Traditional | 04/04/2014SE |
| K133939 | Modified Distal Radius Plating SystemHRS · Traditional | 04/01/2014SE |
| K133354 | Peri-Prosthetic Cable SystemJDQ · Traditional | 01/27/2014SE |
| K132873 | Vanguard XP Knee SystemMBH · Traditional | 12/11/2013SE |
| K131867 | 2.5MM Inline Fusion PlateHRS · Traditional | 10/29/2013SE |
| K131684 | Biolox(R) Delta Ceramic HeadsLZO · Traditional | 10/10/2013SE |
| K132704 | Distal Radius Volar Rim Plate Standard, Distal Radius Volar Rim Plate NarrowLXT · Traditional | 10/09/2013SE |
| K130610 | Sirius Femoral StemJDI · Traditional | 08/30/2013SE |
| K130126 | Signature Personalized Patient Care System - Glenoid Guide SystemMBF · Traditional | 08/06/2013SE |
| K131670 | Lapidus Plate, 3.5MM Inline Fusion Plate, 3.5MM MTP Plate (Left and Right)HRS · Traditional | 07/03/2013SE |
| K130063 | Arcos Trochanter ButtonLPH · Special | 04/19/2013SE |
| K123501 | Oss Modular Stems, Oss Diaphyseal SegmentsJDI · Special | 02/27/2013SE |
| K121183 | Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsPHX · Traditional | 07/26/2012SE |
| K120121 | Comprehensive Reverse Shoulder-Mini BaseplatePHX · Special | 02/16/2012SE |
| K111746 | Comprehensive Segmental Revision System (SRS)KWT · Traditional | 12/15/2011SE |
| K110201 | Explor Radial Head Plating SystemHRS · Traditional | 07/21/2011SE |
| K110145 | Biomet Sports Medicine Juggerknot Soft AnchorMBI · Traditional | 03/04/2011SE |
| K102125 | Patient-Specific Vanguard Femoral ComponetsJWH · Traditional | 02/23/2011SE |
| K093293 | Vanguard 360 Revision Knee SystemJWH · Traditional | 10/22/2010SE |
| K100114 | Fat Concentration SystemMUU · Traditional | 09/29/2010SE |
| K101086 | Taperloc CompleteKWA · Traditional | 09/03/2010SE |
| K093235 | Ringloc + Hybrid Acetabular SystemKWA · Traditional | 04/30/2010SE |
| K091722 | Coaxial Applicator SystemFMF · Traditional | 03/12/2010SE |
| K092150 | Cobalt MV with Gentamicin (Aka Cobalt G-Mv) Bone CementLOD · Traditional | 10/27/2009SE |
| K090757 | Biomet Modular Femoral Revision SystemKWA · Traditional | 09/25/2009SE |
| K090103 | 100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 Hi-WallMAY · Special | 02/11/2009SE |
| K082996 | Biolox Delta Option Ceramic HeadsLZO · Special | 01/15/2009SE |
| K082446 | Biomet Metal-On-Metal Hip Systems- Expanded ContraindicationsKWA · Traditional | 10/15/2008SE |
| K080642 | Comprehensive Reverse ShoulderPHX · Traditional | 07/09/2008SE |
| K080330 | Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress Female…KRO · Traditional | 06/11/2008SE |
| K080361 | Regenerex Tibial ComponentsMBH · Traditional | 04/21/2008SE |
| K080204 | Vanguard Knee System Titanium Femoral ComponentsJWH · Traditional | 03/20/2008SE |
| K072330 | Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation SystemFMF · Traditional | 12/06/2007SE |
| K071569 | Allthread PEEK Anchor with Tantalum MarkerMBI · Special | 07/02/2007SE |
| K071053 | Recap Ha Press-Fit Femoral Resurfacing HeadKXA · Special | 06/29/2007SE |
| K070364 | 100KGY E-Poly Maxrom Acetabular LinersJDI · Special | 05/03/2007SE |
| K070369 | Regenerx Ringloc + Modular Acetabular ShellsLPH · Special | 03/09/2007SE |
| K061312 | 36MM Biolox Delta Ceramic HeadsLZO · Special | 06/06/2006SE |
| K052990 | Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement…KWY · Traditional | 12/16/2005SE |
| K052255 | Arcomxl Polyethylene RX90 Acetabular LinersLPH · Special | 11/23/2005SE |
| K052685 | Orthopedic Salvage System- OssKRO · Special | 10/27/2005SE |
| K050124 | Porous Coated Acetabular ComponentsKWA · Traditional | 10/04/2005SE |
| K051843 | Copeland Eas Humeral Resurfacing HeadsHSD · Traditional | 09/29/2005SE |
| K051569 | Ringloc Bi-Polar Acetabular ComponentJDI · Traditional | 09/29/2005SE |
| K050327 | E-Poly (Vitamin E) Acetabular LinersLPH · Traditional | 09/27/2005SE |
| K051975 | Porous Coated Discovery ElbowJDC · Special | 09/06/2005SE |
| K050222 | Vanguard Anterior Stabilized Tibial BearingsMBH · Special | 08/16/2005SE |
| K051570 | Avl Hinge Knee SystemKRO · Traditional | 08/05/2005SE |
| K051385 | Explor Modular Radial Head Replacement DeviceKWI · Traditional | 08/05/2005SE |
| K043547 | Compress Segmental Femoral Replacement SystemKWA · Traditional | 08/05/2005SE |
| K051496 | Cobalt Bone CementLOD · Traditional | 08/04/2005SE |
| K051532 | Cobalt G HV Bone CementLOD · Traditional | 08/03/2005SE |
| K050210 | Disposable Cement Spacer Molds for Temporary Knee ProsthesesJWH · Traditional | 07/19/2005SE |
| K051411 | Arcomxl Polyethylene Liners and Biolox Delta HeadsLZO · Special | 06/29/2005SE |
| K050441 | Taper 2 Porous Femoral StemJDI · Traditional | 06/29/2005SE |
| K050251 | Balance Hip SystemKWA · Traditional | 05/27/2005SE |
| K042989 | RX90 Low Profile Acetabular SystemLPH · Traditional | 04/28/2005SE |
| K042091 | Biolox Delta Ceramic HeadsLZO · Traditional | 03/25/2005SE |
| K042051 | Arcomxl Polyethylene LinersLPH · Traditional | 03/08/2005SE |
| K043100 | Bio-Modular Shoulder System with Hydroxyapatite (Ha) Coated Glenoid ComponentsMBF · Special | 02/17/2005SE |
| K042757 | Vanguard SSK Knee SystemJWH · Traditional | 02/11/2005SE |
| K043505 | Discovery-Mosaic Total Humerus SystemKWT · Traditional | 02/09/2005SE |
| K042774 | Mallory-Head Modular Calcar Stems with Interlocking SlotsLPH · Traditional | 01/21/2005SE |
| K043537 | Taperloc 12/14 Taper Femoral ComponentsLPH · Special | 01/14/2005SE |
| K043280 | Mimix MP Bone Void FillerGXP · Special | 12/21/2004SE |
| K042841 | M2A/C2A Acetabular SystemJDL · Traditional | 12/21/2004SE |
| K042552 | Bio-Core Interference ScrewHWC · Traditional | 12/14/2004SE |
| K042409 | Modular Arthrodesis NailHSB · Traditional | 12/02/2004SE |
| K042029 | X-Series Integral RPP Femoral ComponentsLPH · Special | 11/09/2004SE |
| K042093 | Vanguard M Series Unicondylar Tibial BearingsHRY · Traditional | 11/01/2004SE |
| K041988 | Arthrotek Meniscal Hybrid DeviceJDR · Traditional | 10/20/2004SE |
| K042032 | Maestro Total WristJWJ · Traditional | 10/07/2004SE |
| K042037 | M2A Magnum SystemKWA · Traditional | 10/01/2004SE |
| K041352 | Compress Distal Femoral Replacement SystemKRO · Traditional | 07/30/2004SE |
| K031454 | Acumen Surgical Navigation SystemHAW · Traditional | 07/08/2004SE |
| K040611 | Modular Radial Head Replacement DeviceKWI · Traditional | 06/04/2004SE |
| K033489 | Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…MBH · Traditional | 06/02/2004SE |
| K041046 | Maxim Accel (Vanguard) Ps+ BearingsJWH · Special | 05/21/2004SE |
| K040475 | Micromax Suture AnchorHWC · Traditional | 05/21/2004SE |
| K033611 | Calcigen -Nap Bone Void FillerMQV · Traditional | 04/27/2004SE |
| K033871 | Im Total FemurJDI · Traditional | 04/16/2004SE |
| K033506 | Comprehensive Humeral Fracture Positioning SleeveKWS · Traditional | 02/02/2004SE |
| K033280 | Discovery Elbow-Mosaic Distal Humeral Replacement SystemJDC · Traditional | 12/19/2003SE |
| K031804 | Compress Distal Femoral ReplacementKRO · Traditional | 12/18/2003SE |
| K030086 | Palacos R Bone Cement with GentamicinLOD · Traditional | 12/17/2003SE |
| K033519 | Cannulated Arthrorivet and Cannulated RC ArthrorivetHRS · Special | 12/05/2003SE |
| K032895 | Bi-Angular Shoulder SystemMBF · Traditional | 11/20/2003SE |
| K033233 | Lactosorb Tibial L-15 Screw and WasherHWC · Special | 11/05/2003SE |
| K031280 | Ultra-Drive 3JDX · Traditional | 09/22/2003SE |
| K031337 | Acumen Surgical Navigation SystemHAW · Traditional | 09/15/2003SE |
| K032507 | Interlok Bio-Modular Humeral StemsKWT · Special | 09/05/2003SE |
| K032396 | Ringloc 36MM Line and Modular Femoral HeadsJDI · Special | 08/21/2003SE |
| K030055 | Mallory/Head Total Hip System; Ha Mallory/Head Total Hip System; Bi-Metric Femoral…LPH · Traditional | 08/11/2003SE |
| K031693 | Mallory/Head Modular Calcar with and Without HaLPH · Traditional | 08/06/2003SE |
| K031734 | Generation 4 Polished Femoral Hip ProsthesisJDI · Special | 07/01/2003SE |
| K030861 | Ha Pmi Flanged Acetabular ComponentLPH · Traditional | 06/12/2003SE |
| K030710 | Bio-Modular Shoulder SystemKWT · Traditional | 06/04/2003SE |
| K031334 | Texas T - PlateHRS · Traditional | 05/22/2003SE |
| K011399 | Biomet Craniofacial Acrylic CementGXP · Traditional | 05/05/2003SE |
| K030555 | GPS Platelet Separation Kit with Anticoagulant Acd-AJQC · Traditional | 04/11/2003SE |
| K030501 | X-Series Integral Lateralized Hip ComponentsLPH · Special | 03/20/2003SE |
| K030446 | Repicci Locked Keel Tibial BearingHRY · Special | 03/06/2003SE |
| K030178 | Calcigen Psi Bone Graft SubstituteMQV · Traditional | 02/26/2003SE |
| K030047 | Freedom Constrained LinersKWZ · Special | 01/23/2003SE |
| K024022 | Osteo-Cable SleeveHXN · Special | 01/23/2003SE |
| K023546 | Maxim Accel Knee SystemJWH · Traditional | 01/17/2003SE |
| K021992 | DHS Disposable Hood SystemFYA · Traditional | 01/14/2003SE |
| K024037 | Narrow Ascent Interlok Femoral ComponentsJWH · Special | 12/30/2002SE |
| K022952 | Modular Head Bone ScrewHWC · Traditional | 12/02/2002SE |
| K023409 | Ha X-Series Bi-Metric Hip Femoral ComponentsLPH · Special | 11/08/2002SE |
| K021728 | Ringloc Constrained Liners IIKWZ · Traditional | 10/25/2002SE |
| K022079 | Short and Long Soft Tissue AttachmentKWT · Traditional | 09/24/2002SE |
| K011531 | Calcium Phosphate Granular Bone Void FillerMQV · Traditional | 09/06/2002SE |
| K022531 | 2MM Pediatric Flex NailHTY · Special | 08/26/2002SE |
| K021786 | Titanium Ankle Arthrodesis NailHSB · Traditional | 08/26/2002SE |
| K022094 | Par 5 Acetabular Component with & Without Hydroxyapatite CoatingJDI · Special | 07/25/2002SE |
| K021927 | Platelet Concentrate Separation Kit for Celsep Centrifuge SystemLXG · Special | 07/12/2002SE |
| K021828 | Small Hammer Toe PinHWC · Special | 07/01/2002SE |
| K021071 | PCCS Graft Delivery SystemFMF · Traditional | 07/01/2002SE |
| K021832 | Arthrotek Resorbable No-Profile Lactosorb L-15 Screw & WasherHWC · Special | 06/26/2002SE |
| K021621 | Fixed Bearing Uni ComponentHRY · Special | 06/05/2002SE |
| K021559 | Ascent All-Poly PS Tibial BearingsJWH · Special | 06/05/2002SE |
| K021260 | Reduced Size Oncology Salvage SystemKRO · Traditional | 06/05/2002SE |
| K021380 | Oss Les Proximal Femoral ComponentJDI · Special | 05/28/2002SE |
| K021182 | Radiolucent Colles Compression/Distraction BarJDW · Special | 05/13/2002SE |
| K020819 | Distal Radius Plating SystemHRS · Traditional | 04/22/2002SE |
| K020970 | Modification to Oncology Salvage System (Oss)JDI · Special | 04/04/2002SE |
| K020761 | Power Tek IIHRX · Special | 04/03/2002SE |
| K020580 | X-Series Bi-Metric Hip Femoral ComponentsLPH · Special | 03/22/2002SE |
| K012551 | Liverpool Radial Head Replacement DeviceKWI · Traditional | 01/30/2002SE |
| K012569 | Modification to: Injectable MimixGXP · Special | 12/21/2001SE |
| K011139 | Lorenz Lactosorb Panels and FastenersHRS · Traditional | 12/20/2001SE |
| K993836 | Generation 4 Bone CementLOD · Traditional | 12/19/2001SE |
| K011451 | Reunite Fusion ScrewHWC · Traditional | 12/10/2001SE |
| K012572 | Soft Tissue Screw and WasherHWC · Traditional | 12/03/2001SE |
| K012798 | Intex ScrewHWC · Traditional | 11/16/2001SE |
| K010635 | Interlok / Ha Copeland Resurfacing HeadsMBF · Traditional | 08/20/2001SE |
| K012348 | Maxim RPG PS Femoral ComponentJWH · Special | 08/15/2001SE |
| K003281 | Lactosorb RapidflapJEY · Traditional | 08/07/2001SE |
| K011522 | Resorbable Bone PinsHTY · Traditional | 07/31/2001SE |
| K012019 | Color Buffed (CB) DDH Femoral StemJDI · Special | 07/20/2001SE |
| K011455 | Biomet Oncology Salvage System (Oss) Taper Stacking AdapterJDI · Traditional | 07/18/2001SE |
| K011138 | Oxford Unicompartmental Knee Femoral ComponentHRY · Traditional | 07/10/2001SE |
| K011110 | M2A Acetabular SystemKWA · Traditional | 07/02/2001SE |
| K011554 | Lorenz Lactosorb Vocal Medialization ImplantMIX · Traditional | 06/26/2001SE |
| K011137 | Resorbable Hammertoe PinJDW · Traditional | 06/19/2001SE |
| K011795 | Worland Unicondylar Tibial BearingHRY · Special | 06/13/2001SE |
| K011509 | Barrett Unicondylar Tibial BearingHRY · Special | 06/13/2001SE |
| K011237 | Lactosorb Plates, Meshes, and Panels/SheetsHRS · Special | 05/23/2001SE |
| K011219 | Ascent Knee SystemJWH · Special | 05/18/2001SE |
| K010348 | Tantalum Beads - Radiographic MarkerNEU · Traditional | 05/03/2001SE |
| K010774 | Avl Hinge Knee SystemKRO · Special | 04/13/2001SE |
| K003494 | Mimix Bone Replacement SystemLYC · Traditional | 04/09/2001SE |
| K010560 | Portrait Femoral ComponentLZO · Special | 03/20/2001SE |
| K001581 | Lactosorb 5.0 MM WasherHWC · Traditional | 03/20/2001SE |
| K010212 | Offset Tibial TrayMBV · Special | 02/14/2001SE |
| K003493 | 3I Calcium Sodium Phosphate Bone CementLYC · Traditional | 02/09/2001SE |
| K010027 | Maxim Knee SystemJWH · Special | 01/12/2001SE |
| K003253 | Biomet's Minimally Constrained ElbowJDC · Traditional | 01/12/2001SE |
| K003273 | Lactosorb Screw AnchorMAI · Traditional | 01/11/2001SE |
| K003240 | Biomet External Wrist PlateLXT · Traditional | 12/29/2000SE |
| K003363 | M2A 32MM Taper SystemKWY · Special | 12/15/2000SE |
| K003044 | Copeland Resurfacing HeadsHSD · Traditional | 12/13/2000SE |
| K003429 | Malloy/Head Lateralized Press-Fit FemoralLPH · Special | 11/30/2000SE |
| K003428 | Iss Offset HeadsHSD · Special | 11/24/2000SE |
| K002757 | Oncology Salvage SystemJDI · Traditional | 11/24/2000SE |
| K003296 | Biomet SCK Knee SystemJWH · Special | 11/06/2000SE |
| K003294 | Biomet Lateral Troch PlateJDW · Special | 11/03/2000SE |
| K003131 | Modification to: Radiolucent Colles Fracture KitJDW · Special | 11/02/2000SE |
| K002423 | Lactosorb Push ScrewDZL · Traditional | 10/20/2000SE |
| K002998 | Biomet Bi-Polar Shoulder SystemKWT · Special | 10/06/2000SE |
| K002772 | Ascent XXL Closed Box Femoral ComponentJWH · Special | 10/04/2000SE |
| K002735 | Ascent XXL Open Box Femoral ComponentJWH · Special | 09/19/2000SE |
| K002678 | Ascent Knee SystemJWH · Special | 09/19/2000SE |
| K002379 | M2A 28MM Ringloc LinerKWA · Special | 08/31/2000SE |
| K001760 | Radiolucent Colles Fracture KitLXT · Abbreviated | 08/31/2000SE |
| K001580 | Gross Femoral ComponentMEH · Traditional | 08/17/2000SE |
| K984390 | Lactosorb Panels and FastenersHRS · Traditional | 08/07/2000SE |
| K002106 | New Bio-Moore Endo Head, Taper AdapterJDI · Special | 07/27/2000SE |
| K001350 | Patient Matched Titanium Alloy TrochleaKRR · Traditional | 07/26/2000SE |
| K001376 | Ti-Max Protrusio CageJDI · Traditional | 07/20/2000SE |
| K001271 | Samarco Spider PlatesKTW · Traditional | 07/14/2000SE |
| K000683 | Modified Single Axle Total ElbowJDC · Special | 06/27/2000SE |
| K000978 | Anatomic Total Knee ProsthesisJWH · Traditional | 06/22/2000SE |
| K000760 | Reach Femoral ComponentLPH · Traditional | 05/23/2000SE |
| K993438 | Metal on Metal Acetabular SystemKWA · Traditional | 05/18/2000SE |
| K001010 | Ascent Knee Revision Femoral StemJWH · Special | 04/27/2000SE |
| K990830 | Mallory/Head Calcar Replacement with Interlocking Slots Bi-Metric Porous Collared Stem…LPH · Traditional | 04/11/2000SE |
| K000764 | Pediatric Fixation RodsJDS · Special | 04/06/2000SE |
| K000538 | Mallory/Head Lateralized Press-Fit FemoralLPH · Special | 03/15/2000SE |
| K000335 | Mallory-Head Modular Calcar Total Hip SystemLPH · Special | 02/25/2000SE |
| K000334 | Impact Modular Total Hip SystemLPH · Special | 02/16/2000SE |
| K994184 | PLR Splined Revision StemLZO · Traditional | 02/15/2000SE |
| K993972 | Disposable Infusion Pump KitMEB · Traditional | 02/07/2000SE |
| K000254 | Par 5 Acetabular ComponentJDI · Special | 02/07/2000SE |
| K994007 | Mallory/Head Smooth Femoral ComponentJDI · Traditional | 02/04/2000SE |
| K994038 | Modular Reach HipLPH · Special | 12/22/1999SE |
| K993956 | Titanium Pediatric Femoral NailHSB · Special | 12/20/1999SE |
| K992355 | Lactosorb Trauma Plating SystemHRS · Special | 12/20/1999SE |
| K990290 | Craniofacial Calcium Phosphate Ceramic Bone FillerGXP · Traditional | 11/18/1999SE |
| K993510 | Modified BMP Trochanteric PlatesHRS · Special | 11/16/1999SE |
| K992899 | Bio-Modular Shoulder Offset Humeral HeadsKWS · Traditional | 10/21/1999SE |
| K993159 | Maxim Knee SystemJWH · Special | 10/14/1999SE |
| K993025 | Modification to Bone Mulch Screw SystemHWC · Special | 10/08/1999SE |
| K992903 | Color Buffed Cemented FemoralJDI · Special | 09/17/1999SE |
| K992119 | Bio-Modular Shoulder SystemKWS · Traditional | 09/13/1999SE |
| K991990 | Tri-Polar SystemKWY · Traditional | 09/10/1999SE |
| K992158 | Lactosorb SheetsJEY · Traditional | 08/20/1999SE |
| K991585 | Bipolar Shoulder ProsthesisKWT · Traditional | 08/18/1999SE |
| K991753 | Maxim Removable Molded Poly TibiaJWH · Traditional | 08/17/1999SE |
| K991763 | Lactosorb Hand SystemHRS · Traditional | 07/30/1999SE |
| K991708 | Zirconia 22.22MM Ceramic Modular HeadsLZO · Abbreviated | 07/30/1999SE |
| K984054 | Agc V2 Revision Knee SystemJWH · Traditional | 07/30/1999SE |
| K992167 | Performance Knee SystemJWH · Special | 07/28/1999SE |
| K991807 | Titanium Low Profile ScrewsLPH · Traditional | 07/08/1999SE |
| K992058 | Bi-Metric Ccocr Head/Neck Replacement SystemJDI · Special | 07/01/1999SE |
| K991987 | Color Buffed Answer Cemented FemoralJDI · Special | 06/28/1999SE |
| K991009 | RC ButtressMAI · Traditional | 06/23/1999SE |
| K991428 | Ascent Knee SystemJWH · Special | 05/21/1999SE |
| K991298 | Bone Mulch Screw SystemHWC · Traditional | 05/14/1999SE |
| K983036 | Single Axle Total ElbowJDC · Traditional | 04/30/1999SE |
| K990291 | Lactosorb Bone PinHTY · Traditional | 03/23/1999SE |
| K981996 | Titanium Femoral ComponentJWH · Traditional | 03/10/1999SE |
| K984623 | Maxim Removable Molded Poly TibiaJWH · Traditional | 03/05/1999SE |
| K990032 | Modular Protusio CupJDI · Traditional | 02/18/1999SE |
| K984296 | Lateralized Intergral Porous Primary Femoral ComponentLPH · Traditional | 02/18/1999SE |
| K984408 | 130 Modified Integral Femoral ComponentLPH · Traditional | 02/12/1999SE |
| K984154 | Apf Porous Coated Line ExtensionJDI · Traditional | 02/11/1999SE |
| K984209 | Stainless Steel Taper Foreman Nail Cannulated Screw, Stainless Steel Cannulated Screw…HWC · Traditional | 02/03/1999SE |
| K982095 | Lactosorb Meniscal Repair DeviceMAI · Traditional | 01/27/1999SE |
| K984028 | The New Bio-Moore Endo HeadsKWL · Traditional | 01/19/1999SE |
| K983967 | Pediatric Cannulated Osteotomy PlatesHRS · Traditional | 12/16/1998SE |
| K983641 | Holland Femoral Nail SystemHSB · Traditional | 12/04/1998SE |
| K983452 | Nelson Resurfacing HeadKXA · Traditional | 12/03/1998SE |
| K983710 | 150MM Cocr Bimetric Head/Neck Replacement Hip Stem- Color Buff FinishJDI · Traditional | 12/02/1998SE |
| K983035 | Custom Flanged Acetabular ComponentLPH · Traditional | 11/23/1998SE |
| K981666 | 2.5 MM Lactosorb ScrewsDZL · Traditional | 11/03/1998SE |
| K982953 | Titanium Intramedullary Nails-Various StylesHSB · Traditional | 10/21/1998SE |
| K982545 | BMP Cable SystemJDQ · Traditional | 10/19/1998SE |
| K982497 | Arthrotek Interference ScrewHWC · Traditional | 10/16/1998SE |
| K982982 | Mini-Fixator for Colles FracturesHRS · Traditional | 10/13/1998SE |
| K982869 | Ascent SystemJWH · Special | 09/22/1998SE |
PMA approvals
- P050009 C2 A-Taper Acetabular System · 12/16/2005 · 6 supplements
Recalls (latest 200)
| Recall | Product | Initiated |
|---|---|---|
| Z-2871-2026 Class II | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description:…Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw… | 07/01/2026Open, Classified |
| Z-2870-2026 Class II | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description:…Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw… | 07/01/2026Open, Classified |
| Z-2869-2026 Class II | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description:…Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw… | 07/01/2026Open, Classified |
| Z-2868-2026 Class II | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description:…Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw… | 07/01/2026Open, Classified |
| Z-2867-2026 Class II | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description:…Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw… | 07/01/2026Open, Classified |
| Z-0212-2026 Class II | BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834…There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant… | 09/23/2025Open, Classified |
| Z-2619-2025 Class II | Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the… | 09/09/2025Open, Classified |
| Z-0477-2025 Class II | JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may… | 10/21/2024Open, Classified |
| Z-2179-2024 Class II | RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip…41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint… | 05/17/2024Open, Classified |
| Z-1607-2024 Class II | Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082.…Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process. | 03/13/2024Open, Classified |
| Z-0570-2024 Class II | Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02One product complaint was received reporting that there was an incorrect adapter in the packaging. An… | 11/02/2023Open, Classified |
| Z-0569-2024 Class II | Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01One product complaint was received reporting that there was an incorrect adapter in the packaging. An… | 11/02/2023Open, Classified |
| Z-0388-2024 Class II | Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful…Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or… | 10/09/2023Open, Classified |
| Z-0387-2024 Class II | Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful…Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or… | 10/09/2023Open, Classified |
| Z-0386-2024 Class II | Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful…Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or… | 10/09/2023Open, Classified |
| Z-0385-2024 Class II | Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful…Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or… | 10/09/2023Open, Classified |
| Z-0384-2024 Class II | Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsuccessful…Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or… | 10/09/2023Open, Classified |
| Z-0383-2024 Class II | Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsuccessful…Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or… | 10/09/2023Open, Classified |
| Z-0382-2024 Class II | Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful…Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or… | 10/09/2023Open, Classified |
| Z-0381-2024 Class II | Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful…Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or… | 10/09/2023Open, Classified |
| Z-0380-2024 Class II | Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful…Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or… | 10/09/2023Open, Classified |
| Z-0379-2024 Class II | Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful…Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or… | 10/09/2023Open, Classified |
| Z-0378-2024 Class II | Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessful…Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or… | 10/09/2023Open, Classified |
| Z-0377-2024 Class II | Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful…Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or… | 10/09/2023Open, Classified |
| Z-0376-2024 Class II | Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful…Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or… | 10/09/2023Open, Classified |
| Z-0375-2024 Class II | Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful…Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or… | 10/09/2023Open, Classified |
| Z-0374-2024 Class II | Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful…Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or… | 10/09/2023Open, Classified |
| Z-0373-2024 Class II | Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of unsuccessful…Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or… | 10/09/2023Open, Classified |
| Z-0372-2024 Class II | Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful…Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or… | 10/09/2023Open, Classified |
| Z-0371-2024 Class II | Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful…Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or… | 10/09/2023Open, Classified |
| Z-0370-2024 Class II | Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful…Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or… | 10/09/2023Open, Classified |
| Z-1284-2023 Class II | G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number…The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C… | 02/06/2023Open, Classified |
| Z-1043-2023 Class II | (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint…Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). | 12/29/2022Open, Classified |
| Z-1042-2023 Class II | (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint…Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). | 12/29/2022Open, Classified |
| Z-1018-2023 Class II | Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of…Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required… | 12/15/2022Open, Classified |
| Z-1036-2023 Class II | OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the…Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement | 11/29/2022Open, Classified |
| Z-0812-2022 Class II | BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM…Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile… | 02/14/2022Terminated |
| Z-0811-2022 Class II | BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices…Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile… | 02/14/2022Terminated |
| Z-0810-2022 Class II | BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item #…Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile… | 02/14/2022Terminated |
| Z-0809-2022 Class II | BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item…Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile… | 02/14/2022Terminated |
| Z-0677-2022 Class II | Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item…The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating.… | 01/07/2022Terminated |
| Z-0676-2022 Class II | Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item…The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating.… | 01/07/2022Terminated |
| Z-0675-2022 Class II | Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long Item…The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating.… | 01/07/2022Terminated |
| Z-0674-2022 Class II | Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item…The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating.… | 01/07/2022Terminated |
| Z-0673-2022 Class II | Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM…The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating.… | 01/07/2022Terminated |
| Z-0672-2022 Class II | Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM…The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating.… | 01/07/2022Terminated |
| Z-0671-2022 Class II | Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM…The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating.… | 01/07/2022Terminated |
| Z-0670-2022 Class II | Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM…The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating.… | 01/07/2022Terminated |
| Z-2275-2021 Class II | Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM Item Number:…Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and… | 06/02/2021Terminated |
| Z-2274-2021 Class II | Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number:…Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and… | 06/02/2021Terminated |
| Z-2273-2021 Class II | Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Item Number:…Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and… | 06/02/2021Terminated |
| Z-2272-2021 Class II | Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item Number:…Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and… | 06/02/2021Terminated |
| Z-2271-2021 Class II | Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Item Number:…Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and… | 06/02/2021Terminated |
| Z-2270-2021 Class II | Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Item Number:…Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and… | 06/02/2021Terminated |
| Z-2269-2021 Class II | Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item…Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and… | 06/02/2021Terminated |
| Z-2268-2021 Class II | Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number:…Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and… | 06/02/2021Terminated |
| Z-2267-2021 Class II | Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM Item Number:…Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and… | 06/02/2021Terminated |
| Z-2266-2021 Class II | Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM Item Number:…Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and… | 06/02/2021Terminated |
| Z-2265-2021 Class II | Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item Number:…Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and… | 06/02/2021Terminated |
| Z-2264-2021 Class II | Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number:…Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and… | 06/02/2021Terminated |
| Z-2263-2021 Class II | Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number:…Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and… | 06/02/2021Terminated |
| Z-2262-2021 Class II | Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number:…Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and… | 06/02/2021Terminated |
| Z-2261-2021 Class II | Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number:…Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and… | 06/02/2021Terminated |
| Z-2260-2021 Class II | Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number:…Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and… | 06/02/2021Terminated |
| Z-2259-2021 Class II | Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number:…Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and… | 06/02/2021Terminated |
| Z-1131-2021 Class II | Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for…Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder… | 01/15/2021Terminated |
| Z-0882-2021 Class II | A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product…The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide.… | 12/23/2020Terminated |
| Z-0723-2021 Class II | Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for…Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure | 12/01/2020Terminated |
| Z-0631-2021 Class II | RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323230…Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the… | 11/25/2020Terminated |
| Z-0630-2021 Class II | Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation.Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the… | 11/25/2020Terminated |
| Z-0629-2021 Class II | Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product…Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the… | 11/25/2020Terminated |
| Z-0628-2021 Class II | RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage:…Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the… | 11/25/2020Terminated |
| Z-0627-2021 Class II | RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534…Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the… | 11/25/2020Terminated |
| Z-0626-2021 Class II | RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofacial bone.Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the… | 11/25/2020Terminated |
| Z-0625-2021 Class II | PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-405044…Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the… | 11/25/2020Terminated |
| Z-0624-2021 Class II | Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage:…Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the… | 11/25/2020Terminated |
| Z-0623-2021 Class II | OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in…Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the… | 11/25/2020Terminated |
| Z-0622-2021 Class II | M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb…Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the… | 11/25/2020Terminated |
| Z-0621-2021 Class II | Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1.…Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the… | 11/25/2020Terminated |
| Z-0620-2021 Class II | Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number…Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the… | 11/25/2020Terminated |
| Z-0619-2021 Class II | Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398…Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the… | 11/25/2020Terminated |
| Z-0618-2021 Class II | 6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0…Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the… | 11/25/2020Terminated |
| Z-0617-2021 Class II | 4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0…Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the… | 11/25/2020Terminated |
| Z-0616-2021 Class II | 3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm)…Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the… | 11/25/2020Terminated |
| Z-0084-2021 Class II | Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055Product not properly being aligned with the adequate gamma sterilization group and result in the product not… | 09/04/2020Terminated |
| Z-0083-2021 Class II | Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055Product not properly being aligned with the adequate gamma sterilization group and result in the product not… | 09/04/2020Terminated |
| Z-0082-2021 Class II | Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050Product not properly being aligned with the adequate gamma sterilization group and result in the product not… | 09/04/2020Terminated |
| Z-0081-2021 Class II | Biomet Regenerex Primary Taper Cap Item Number 141269Product not properly being aligned with the adequate gamma sterilization group and result in the product not… | 09/04/2020Terminated |
| Z-0097-2021 Class II | (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1…Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system… | 09/03/2020Terminated |
| Z-0093-2021 Class II | Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper…Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1)… | 09/02/2020Terminated |
| Z-2324-2020 Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Item Number:…Distributed to the field without having completed design history files or design transfer activities | 05/14/2020Terminated |
| Z-2323-2020 Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM, Item Number:…Distributed to the field without having completed design history files or design transfer activities | 05/14/2020Terminated |
| Z-2322-2020 Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 7 HOLE 140MM, Item Number:…Distributed to the field without having completed design history files or design transfer activities | 05/14/2020Terminated |
| Z-2321-2020 Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item Number:…Distributed to the field without having completed design history files or design transfer activities | 05/14/2020Terminated |
| Z-2320-2020 Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 11 HOLE 197MM, Item Number:…Distributed to the field without having completed design history files or design transfer activities | 05/14/2020Terminated |
| Z-2319-2020 Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item Number:…Distributed to the field without having completed design history files or design transfer activities | 05/14/2020Terminated |
| Z-2318-2020 Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM, Item Number:…Distributed to the field without having completed design history files or design transfer activities | 05/14/2020Terminated |
| Z-2317-2020 Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM, Item Number:…Distributed to the field without having completed design history files or design transfer activities | 05/14/2020Terminated |
| Z-2316-2020 Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 14 HOLE 227MM, Item Number:…Distributed to the field without having completed design history files or design transfer activities | 05/14/2020Terminated |
| Z-2315-2020 Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Number:…Distributed to the field without having completed design history files or design transfer activities | 05/14/2020Terminated |
| Z-2314-2020 Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234MM Item…Distributed to the field without having completed design history files or design transfer activities | 05/14/2020Terminated |
| Z-2313-2020 Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 140MM Item…Distributed to the field without having completed design history files or design transfer activities | 05/14/2020Terminated |
| Z-2312-2020 Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, Item…Distributed to the field without having completed design history files or design transfer activities | 05/14/2020Terminated |
| Z-2311-2020 Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460…Distributed to the field without having completed design history files or design transfer activities | 05/14/2020Terminated |
| Z-2310-2020 Class II | A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960 -…Distributed to the field without having completed design history files or design transfer activities | 05/14/2020Terminated |
| Z-2309-2020 Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number:…Distributed to the field without having completed design history files or design transfer activities | 05/14/2020Terminated |
| Z-2308-2020 Class II | A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product…Distributed to the field without having completed design history files or design transfer activities | 05/14/2020Terminated |
| Z-2307-2020 Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 2.7MM, Item Number:…Distributed to the field without having completed design history files or design transfer activities | 05/14/2020Terminated |
| Z-2306-2020 Class II | A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number:…Distributed to the field without having completed design history files or design transfer activities | 05/14/2020Terminated |
| Z-2305-2020 Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK SET SCREW, Item Number: 110017551 -…Distributed to the field without having completed design history files or design transfer activities | 05/14/2020Terminated |
| Z-2304-2020 Class II | Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product…Distributed to the field without having completed design history files or design transfer activities | 05/14/2020Terminated |
| Z-2303-2020 Class II | Biomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008466 - Product…Distributed to the field without having completed design history files or design transfer activities | 05/14/2020Terminated |
| Z-2300-2020 Class II | Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI:…The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter… | 05/11/2020Terminated |
| Z-2363-2020 Class II | Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003Device and tray that houses the device did not pass steam sterilization process validation testing | 05/01/2020Terminated |
| Z-2362-2020 Class II | Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235Device and tray that houses the device did not pass steam sterilization process validation testing | 05/01/2020Terminated |
| Z-2156-2020 Class II | Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model…Potential presence of elevated endotoxin levels that exceed the specification limit | 04/17/2020Terminated |
| Z-2155-2020 Class II | Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray…Potential presence of elevated endotoxin levels that exceed the specification limit | 04/17/2020Terminated |
| Z-2154-2020 Class II | Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM…Potential presence of elevated endotoxin levels that exceed the specification limit | 04/17/2020Terminated |
| Z-2153-2020 Class II | Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM…Potential presence of elevated endotoxin levels that exceed the specification limit | 04/17/2020Terminated |
| Z-2152-2020 Class II | Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM…Potential presence of elevated endotoxin levels that exceed the specification limit | 04/17/2020Terminated |
| Z-2151-2020 Class II | Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM…Potential presence of elevated endotoxin levels that exceed the specification limit | 04/17/2020Terminated |
| Z-2150-2020 Class II | Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620…Potential presence of elevated endotoxin levels that exceed the specification limit | 04/17/2020Terminated |
| Z-2149-2020 Class II | Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM…Potential presence of elevated endotoxin levels that exceed the specification limit | 04/17/2020Terminated |
| Z-2148-2020 Class II | Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left…Potential presence of elevated endotoxin levels that exceed the specification limit | 04/17/2020Terminated |
| Z-2147-2020 Class II | Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard -…Potential presence of elevated endotoxin levels that exceed the specification limit | 04/17/2020Terminated |
| Z-2146-2020 Class II | Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A…Potential presence of elevated endotoxin levels that exceed the specification limit | 04/17/2020Terminated |
| Z-2145-2020 Class II | Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28…Potential presence of elevated endotoxin levels that exceed the specification limit | 04/17/2020Terminated |
| Z-2144-2020 Class II | Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366…Potential presence of elevated endotoxin levels that exceed the specification limit | 04/17/2020Terminated |
| Z-1750-2020 Class II | Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number…There were unknown bioburden levels prior to sterilization, which may affect sterility of the product. | 03/13/2020Terminated |
| Z-1670-2020 Class II | BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1669-2020 Class II | BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1668-2020 Class II | BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1667-2020 Class II | BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1666-2020 Class II | BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1665-2020 Class II | BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1664-2020 Class II | BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1663-2020 Class II | BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1662-2020 Class II | BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1661-2020 Class II | BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1660-2020 Class II | BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1659-2020 Class II | BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1658-2020 Class II | BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1657-2020 Class II | BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1656-2020 Class II | BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1655-2020 Class II | BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1654-2020 Class II | BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1653-2020 Class II | BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1652-2020 Class II | BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1651-2020 Class II | BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1650-2020 Class II | BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1649-2020 Class II | BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1648-2020 Class II | BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1647-2020 Class II | BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1646-2020 Class II | BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1645-2020 Class II | BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1644-2020 Class II | BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1643-2020 Class II | BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1642-2020 Class II | BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1641-2020 Class II | BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1640-2020 Class II | BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1639-2020 Class II | BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1638-2020 Class II | BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1615-2020 Class II | Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper…Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged… | 02/25/2020Terminated |
| Z-1543-2020 Class II | Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage:…A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem. | 02/17/2020Terminated |
| Z-1173-2018 Class II | Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for…During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction… | 02/28/2018Terminated |
| Z-2240-2016 Class II | TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet…The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain… | 06/10/2016Terminated |
| Z-1814-2016 Class II | PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the…The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery… | 04/11/2016Terminated |
| Z-1828-2016 Class II | Various trauma and sports medicine instruments and implants. Fastener, fixation…Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1827-2016 Class II | Various trauma and sports medicine instruments and implants. Orthopedic manual surgical…Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1826-2016 Class II | Various trauma and sports medicine instruments and implants. Spinal interlaminal…Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1825-2016 Class II | Various trauma and sports medicine instruments and implants. Appliance, fixation…Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1824-2016 Class II | Various trauma and sports medicine instruments and implants. Passer.Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1823-2016 Class II | Various trauma and sports medicine instruments and implants. Screw, fixation, bone.Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1822-2016 Class II | Various trauma and sports medicine instruments and implants. Pin, fixation, smooth.Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1821-2016 Class II | Various trauma and sports medicine instruments and implants. Bit, drill.Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1820-2016 Class II | Various trauma and sports medicine instruments and implants. Reamer.Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1819-2016 Class II | Various trauma and sports medicine instruments and implants. Rod, fixation…Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1818-2016 Class II | Various trauma and sports medicine instruments and implants. Arthroscope.Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1817-2016 Class II | Various trauma and sports medicine instruments and implants. Plate, fixation, bone.Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1816-2016 Class II | Various trauma and sports medicine instruments and implants. cannula, surgical, general…Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1815-2016 Class II | Various trauma and sports medicine instruments and implants. guide, surgical, instrumentInsufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1318-2016 Class II | All instrumentation associated with the Prelude PF Resurfacing Knee System.Inadequate design control. | 03/09/2016Terminated |
| Z-1093-2016 Class II | Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) Biomet…Zimmer Biomet Inc. Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor)… | 02/16/2016Terminated |
| Z-0885-2016 Class II | HipLOC CHS Plate/Lag Screw IntroducerA complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the… | 02/16/2016Terminated |
| Z-1265-2016 Class II | Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total…The anterior/posterior (AP) dimension may be oversized by 0.016. If the femoral component does not fit as… | 02/05/2016Terminated |
| Z-1082-2016 Class II | Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates…Components of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in surgery, less… | 01/29/2016Terminated |
| Z-0472-2016 Class II | Green Mamba Suture PasserThere may be a separation and an insufficient weld between the spring and washer. The weld between the… | 12/02/2015Terminated |
| Z-0471-2016 Class II | Black Mamba Suture PasserThere may be a separation and an insufficient weld between the spring and washer. The weld between the… | 12/02/2015Terminated |
| Z-0450-2016 Class II | A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation…These screws have a single lead (instead of a triple lead) thread. The screw may sit proud in the plate, If… | 11/20/2015Terminated |
| Z-0650-2016 Class II | Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm…PMMA is listed as a material on the label but the product does not contain PMMA. | 11/17/2015Terminated |
| Z-2483-2015 Class II | Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis.The device was assembled without screw hole plugs. | 07/28/2015Terminated |
| Z-2072-2015 Class II | A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.Medium Bone Plate Forceps was assembled with the incorrect grip arm tip. Potential that the surgeon will be… | 06/17/2015Terminated |
| Z-2058-2015 Class II | A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screwSterile packaging was not sealed. The implantation of an unsterile screw may lead to infection. | 06/04/2015Terminated |
| Z-2046-2015 Class II | A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a…The thread location on one of the thread holes is offset from the axis of the predrill hole. The threads are… | 06/04/2015Terminated |
| Z-2065-2015 Class II | Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide. The Oxford…Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an interference… | 06/03/2015Terminated |
| Z-1945-2015 Class II | Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for…Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part… | 06/03/2015Terminated |
| Z-1944-2015 Class II | Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for…Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part… | 06/03/2015Terminated |
| Z-1741-2015 Class II | Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for…Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. This prevents… | 05/01/2015Terminated |
| Z-1798-2015 Class II | Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.The Left and Right orientation of the trial was incorrectly etched on one side. When the instrument is… | 04/22/2015Terminated |
| Z-1757-2015 Class III | Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD…Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect… | 04/16/2015Terminated |