Smith & Nephew, Inc.
Medical device manufacturer in Memphis, TN.
547510(k) clearances
5PMA approvals
443recalls
Device types
- JWH Prosthesis, Knee, Patellofemorotibial… 49
- HRS Plate, Fixation, Bone 37
- LPH Prosthesis, Hip, Semi-Constrained… 32
- HWC Screw, Fixation, Bone 27
- LZO Prosthesis, Hip, Semi-Constrained… 24
- MBI Fastener, Fixation, Nondegradable, Soft… 22
- HRX Arthroscope 19
- KTT Appliance, Fixation, Nail/Blade/Plate… 16
- GCJ Laparoscope, General & Plastic Surgery 15
- OMP Negative Pressure Wound Therapy Powered… 14
- MEH Prosthesis, Hip, Semi-Constrained… 13
- HSX Prosthesis, Knee, Femorotibial… 13
- JDS Nail, Fixation, Bone 12
- MBH Prosthesis, Knee, Patello/Femorotibial… 12
- KWS Prosthesis, Shoulder, Semi-Constrained… 11
- GAT Suture, Nonabsorbable, Synthetic… 11
- HSB Rod, Fixation, Intramedullary And Accessories 11
- MAI Fastener, Fixation, Biodegradable, Soft… 10
- GEI Electrosurgical, Cutting & Coagulation &… 10
- HIH Hysteroscope (And Accessories) 10
510(k) clearances (latest 300)
| 510(k) | Device | Decision |
|---|---|---|
| K261462 | LANDMARK Total Knee SystemMBH · Traditional | 09/08/2026SE |
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE…MBI · Special | 07/09/2026SE |
| K254084 | AETOS Shoulder System - CONCELOC GlenoidsKWS · Traditional | 04/06/2026SE |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0KWS · Traditional | 10/29/2025SE |
| K252129 | AETOS Shoulder System Stemless Humeral ProsthesisPKC · Traditional | 10/03/2025SE |
| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…MBI · Special | 06/25/2025SE |
| K243608 | TRIGEN Stable Lock Nut & WasherJDS · Traditional | 06/12/2025SE |
| K250677 | LEGION Total Knee SystemJWH · Special | 04/02/2025SE |
| K250571 | CATALYSTEM Femoral StemsLZO · Special | 03/28/2025SE |
| K241666 | EVOS Pelvic and Acetabular SystemHRS · Traditional | 02/19/2025SE |
| K243364 | TRIGEN META-TAN Trochanteric Antegrade NailHSB · Traditional | 12/09/2024SE |
| K240716 | AETOS Shoulder System Stemless Humeral ProsthesisPKC · Traditional | 11/20/2024SE |
| K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK)HSX · Traditional | 10/30/2024SE |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…JDI · Traditional | 10/21/2024SE |
| K242375 | OR3O Dual Mobility SystemLPH · Traditional | 10/07/2024SE |
| K240061 | TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemJDS · Traditional | 09/20/2024SE |
| K240487 | EVOS Patella PlatesHRS · Traditional | 09/03/2024SE |
| K241804 | TRIGEN INTERTAN 10S Nail SystemJDS · Traditional | 08/22/2024SE |
| K240381 | CATALYSTEM Femoral StemsLZO · Traditional | 06/27/2024SE |
| K241435 | Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX…MBI · Special | 06/20/2024SE |
| K240113 | CORIOGRAPH Knee Pre-Op PlanPBF · Traditional | 03/18/2024SE |
| K233949 | ACCORD Cable SystemJDQ · Traditional | 03/13/2024SE |
| K233730 | Footprint Mini PK, 3.5mm Suture AnchorMBI · Traditional | 01/17/2024SE |
| K233396 | Cannulated Screw SystemHWC · Traditional | 12/21/2023SE |
| K232667 | OR3O Dual Mobility LinersLPH · Traditional | 10/27/2023SE |
| K232457 | Q-FIX ULTRA All-Suture AnchorMBI · Special | 09/08/2023SE |
| K231376 | Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)MBI · Traditional | 08/09/2023SE |
| K232005 | HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…MBI · Special | 08/04/2023SE |
| K231448 | TANDEM Hip SystemLZY · Traditional | 07/19/2023SE |
| K230761 | TRIGEN META-NAIL Nail SystemJDS · Traditional | 06/14/2023SE |
| K230572 | AETOS Shoulder SystemKWS · Traditional | 06/07/2023SE |
| K223762 | Smith & Nephew ACCORD Cable SystemHRS · Traditional | 05/30/2023SE |
| K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…JWH · Traditional | 05/04/2023SE |
| K230555 | Cemented Tibia Baseplate no Taper with JRNY LockJWH · Special | 03/30/2023SE |
| K222971 | ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…MBI · Traditional | 02/17/2023SE |
| K220847 | AETOS Shoulder SystemKWS · Traditional | 01/03/2023SE |
| K223112 | MAVERICK Mini External Fixation SystemJDW · Traditional | 12/08/2022SE |
| K210980 | Smith & Nephew Intramedullary Nail SystemsHSB · Traditional | 11/14/2022SE |
| K213123 | EVOS Wrist Spanning PlateHRS · Traditional | 10/18/2022SE |
| K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…JDO · Traditional | 09/29/2022SE |
| K221792 | Acute QC Strut and ComponentsOSN · Traditional | 08/25/2022SE |
| K220959 | OR3O Dual Mobility SystemLPH · Traditional | 08/18/2022SE |
| K221939 | Cemented Round Patella with JRNY PegsJWH · Special | 07/26/2022SE |
| K211176 | Smith & Nephew Hip SystemsLPH · Traditional | 07/01/2022SE |
| K220896 | Legion Inserts with JRNY LockJWH · Special | 04/26/2022SE |
| K213827 | TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…KWS · Traditional | 03/11/2022SE |
| K213874 | MAVERICK External Fixation SystemJDW · Traditional | 02/11/2022SE |
| K211330 | R3 Large Head LinersLPH · Traditional | 01/19/2022SE |
| K211221 | Porous Patella and Porous Tibia BaseplateMBH · Traditional | 10/01/2021SE |
| K211512 | VISIONAIRE UK Patient Matched Cutting GuidesHSX · Traditional | 09/16/2021SE |
| K211671 | Journey II Mid-Level Tibial InsertsJWH · Special | 08/17/2021SE |
| K210953 | SMART Taylor Spatial FrameKTT · Traditional | 07/29/2021SE |
| K203175 | POLARSTEM Cemented Femoral StemLZO · Traditional | 07/22/2021SE |
| K211548 | POLARSTEM Calcar Reamer GuideLZO · Traditional | 07/19/2021SE |
| K210837 | Smith & Nephew Plates and ScrewsHRS · Traditional | 06/29/2021SE |
| K211246 | LEGION CR Porous Plus HA Femoral ComponentsMBH · Special | 05/24/2021SE |
| K203566 | Tablet ApplicationODA · Traditional | 05/13/2021SE |
| K210784 | Extended HA Half PinsJDW · Special | 04/02/2021SE |
| K210566 | LEGION Porous CR Narrow Femoral ComponentsMBH · Special | 03/25/2021SE |
| K203393 | Fast-Fix FlexGAT · Traditional | 02/01/2021SE |
| K203405 | EVOS Large Fragment Plating SystemHRS · Traditional | 01/27/2021SE |
| K201253 | Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…KTT · Traditional | 12/08/2020SE |
| K202762 | Circular Fixation with Balanced Cable TransportKTT · Traditional | 11/16/2020SE |
| K201918 | EVOS Large Fragment Plating SystemHRS · Traditional | 11/16/2020SE |
| K201701 | R3 HA Coated Acetabular ShellsMBL · Traditional | 10/06/2020SE |
| K201527 | EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)HRS · Traditional | 07/22/2020SE |
| K201349 | Smith+Nephew ArthroscopesHRX · Traditional | 07/20/2020SE |
| K201198 | S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, AutoclavableGCJ · Traditional | 07/17/2020SE |
| K200227 | Journey II XR Knee InstrumentJWH · Traditional | 06/04/2020SE |
| K200826 | Smith&Nephew VISIONAIRE Patient Matched Cutting BlocksJWH · Special | 04/24/2020SE |
| K193558 | HEALICOIL Knotless Suture AnchorsMAI · Traditional | 03/18/2020SE |
| K200407 | LEGION Inserts with JRNY LockJWH · Special | 03/13/2020SE |
| K193029 | Conquest FNJDO · Traditional | 02/28/2020SE |
| K192876 | INTELLIO Tablet ApplicationODA · Traditional | 02/27/2020SE |
| K191002 | OR3O Dual Mobility SystemLPH · Traditional | 10/31/2019SE |
| K190847 | REDAPT Blade AugmentsLPH · Traditional | 10/25/2019SE |
| K192155 | Smith & Nephew DYONICS 25 Fluid Management SystemHRX · Special | 09/04/2019SE |
| K191211 | JOURNEY II Unicompartmental Knee SystemHSX · Traditional | 07/25/2019SE |
| K190367 | Smith & Nephew Tablet ApplicationQGY · Traditional | 05/21/2019SE |
| K190253 | EVOS Small Fragment Upper Extremity Plates Line AdditionsHRS · Special | 03/11/2019SE |
| K190085 | Journey II Unicompartmental Knee SystemHSX · Special | 02/11/2019SE |
| K183010 | Smith & Nephew VISIONAIRE Patient Matched Cutting BlocksJWH · Special | 11/28/2018SE |
| K182535 | R3 Anteverted LinersMBL · Special | 11/19/2018SE |
| K182109 | REDAPT Modular Acetabular ShellLPH · Traditional | 11/16/2018SE |
| K181366 | REDAPT Porous Acetabular ShellLPH · Traditional | 09/24/2018SE |
| K181533 | EVOS Wrist Fracture Plating SystemHRS · Traditional | 08/09/2018SE |
| K180277 | Smith & Nephew SURESHOT Distal Targeting System V4.0 TargeterOLO · Special | 04/24/2018SE |
| K180334 | LEGION Knee SystemJWH · Special | 03/05/2018SE |
| K172336 | Smith & Nephew Patient Matched Cutting BlocksJWH · Special | 01/10/2018SE |
| K173293 | EVOS Small Fragment Upper Extremity PlatesHRS · Traditional | 01/08/2018SE |
| K172785 | Conquest FNJDO · Special | 12/22/2017SE |
| K171934 | Birmingham Hip (BH) Dual Mobility InsertLPH · Traditional | 11/30/2017SE |
| K171073 | Smith & Nephew, Inc. REDAPT AugmentsLPH · Traditional | 11/21/2017SE |
| K173331 | JOURNEY II XR Knee InstrumentsJWH · Special | 11/16/2017SE |
| K163653 | NOVOS-NAIL Limb Lengthening System (LLS)HSB · Traditional | 10/13/2017SE |
| K172684 | Smith & Nephew, Inc. ANTHOLOGY AFIT Hip StemLPH · Special | 10/03/2017SE |
| K172262 | EVOS Small Fragment Plating SystemHRS · Special | 08/23/2017SE |
| K171794 | Smith & Nephew 25 Fluid Management SystemHRX · Special | 06/27/2017SE |
| K162641 | Smith & Nephew, Inc. R3 Constrained LinerKWZ · Traditional | 06/19/2017SE |
| K170457 | EVOS Small Fragment Lower Extremity PlatesHRS · Traditional | 06/14/2017SE |
| K162996 | INVISIKNOT Ankle Syndesmosis Repair KitHTN · Traditional | 06/08/2017SE |
| K170282 | Smith & Nephew VISIONAIRE Adaptive GuidesJWH · Traditional | 05/22/2017SE |
| K170648 | ANTHEM CR Total Knee SystemJWH · Traditional | 05/11/2017SE |
| K170977 | SURESHOT Distal Targeting System V4.0 Trauma InterfaceOLO · Special | 05/03/2017SE |
| K162303 | REDAPT Sleeved Monolithic Revision StemsMEH · Abbreviated | 05/01/2017SE |
| K170280 | Smith & Nephew SURESHOT Distal Targeting System V4.0OLO · Traditional | 04/28/2017SE |
| K170887 | EVOS Small Fragment Plating SystemHRS · Special | 04/24/2017SE |
| K162775 | Legion Cone SystemJWH · Traditional | 01/13/2017SE |
| K163086 | VLP MINI-MOD 2.0mm Column PlatesHRS · Traditional | 12/21/2016SE |
| K161233 | OXINIUM DH Fermoral HeadsMBL · Traditional | 12/14/2016SE |
| K161264 | TRIGEN Low Profile Bone ScrewsHSB · Special | 11/23/2016SE |
| K161763 | Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal DeviceHIH · Traditional | 11/22/2016SE |
| K162078 | EVOS Small Fragment Plating SystemHRS · Traditional | 11/18/2016SE |
| K160923 | REDAPT Anteverted Cemented LinerJDI · Traditional | 11/17/2016SE |
| K161665 | VLP Wrist Fracture SystemHRS · Traditional | 11/15/2016SE |
| K152163 | Renasys GoOMP · Traditional | 09/29/2016SE |
| K162129 | RENASYS-G Gauze Dressing Kits with Soft PortOMP · Special | 08/31/2016SE |
| K160738 | ZUK Select Knee SystemHSX · Traditional | 06/15/2016SE |
| K153606 | LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera…GCJ · Traditional | 06/02/2016SE |
| K152686 | Conquest FNJDO · Traditional | 03/17/2016SE |
| K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…MBI · Traditional | 12/02/2015SE |
| K150790 | REDAPT Porous Acetabular Shell and Cemented LinerLPH · Traditional | 11/16/2015SE |
| K152976 | VLP Mini-Mod Talus PlatesHRS · Special | 11/12/2015SE |
| K152315 | JOURNEY II Uni Tibial Base and InsertHSX · Special | 10/28/2015SE |
| K150241 | Genesis II XLPE Resurfacing Patellar ComponentsJWH · Traditional | 10/27/2015SE |
| K152726 | JOURNEY II XR Knee SystemJWH · Special | 10/21/2015SE |
| K151902 | REDAPT¿ Revision Femoral SystemLZO · Abbreviated | 09/03/2015SE |
| K152143 | TRUCLEAR Operative Hysteroscope 5C and Sheath 5CHIH · Special | 09/02/2015SE |
| K151118 | Smith and Nephew Legion Hinge Knee SystemKRO · Traditional | 07/28/2015SE |
| K151105 | Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…MAI · Traditional | 07/28/2015SE |
| K143133 | RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing…OMP · Traditional | 07/23/2015SE |
| K151326 | RENASYS¿ EZ PLUS Negative Pressure Wound Therapy DeviceOMP · Special | 07/16/2015SE |
| K143115 | The VersaJet II Hydrosurgery SystemFQH · Traditional | 07/15/2015SE |
| K142979 | RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft…OMP · Traditional | 04/29/2015SE |
| K143739 | POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HALZO · Traditional | 04/20/2015SE |
| K143096 | SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HALZO · Traditional | 03/24/2015SE |
| K143226 | Visionaire Disposable InstrumentsJWH · Traditional | 02/12/2015SE |
| K143172 | ACL SMART SystemMAI · Traditional | 02/04/2015SE |
| K142948 | BIOSURE REGENESORB interference ScrewMAI · Traditional | 01/13/2015SE |
| K142807 | ANTHEM PS Total Knee SystemJWH · Abbreviated | 12/22/2014SE |
| K143050 | VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsHRS · Traditional | 12/18/2014SE |
| K142520 | Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareKTT · Special | 11/20/2014SE |
| K141471 | Journey II XR Knee SystemJWH · Traditional | 11/14/2014SE |
| K141585 | Smith & Nephew Disposable Fin PunchJWH · Traditional | 08/21/2014SE |
| K140879 | Biosure Healicoil PK Interference ScrewMBI · Traditional | 07/21/2014SE |
| K140555 | Journey II BCS Constrained InsertsJWH · Traditional | 05/29/2014SE |
| K133662 | Smith & Nephew Cannulated Captured ScrewHWC · Traditional | 05/15/2014SE |
| K140814 | Evos Mini-Fragment Plating SystemHRS · Special | 05/07/2014SE |
| K132886 | Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemHRS · Traditional | 02/04/2014SE |
| K132296 | D-Rad Smart PackHRS · Traditional | 01/07/2014SE |
| K132015 | Truclear Morcellation System and Truclear MorcellatorsHIH · Traditional | 12/13/2013SE |
| K130708 | Smith & Nephew Patient Matched Cutting BlocksJWH · Traditional | 12/11/2013SE |
| K132079 | TFCC Fast-Fix KitGAT · Traditional | 12/05/2013SE |
| K132357 | Smith & Nephew UltratapeGAT · Special | 10/30/2013SE |
| K132446 | Renasys Ez Max Negative Pressure Wound Therapy DeviceOMP · Special | 10/23/2013SE |
| K132435 | Smith & Nephew Global Femoral Head TrialsLZO · Traditional | 10/22/2013SE |
| K132636 | Dyonics Plan Hip Impingement Planning SystemLLZ · Traditional | 10/17/2013SE |
| K130728 | Polarstem Standard and Lateral Femoral Stems with Ti/HaLZO · Traditional | 10/10/2013SE |
| K130748 | Smith & Nephew Sureshot Distal Targeting System V3.0OLO · Traditional | 08/04/2013SE |
| K123598 | Smith & Nephew, Inc. Hip System InstrumentationJDI · Traditional | 06/28/2013SE |
| K130479 | Ilizarov Drill Tip WiresKTT · Traditional | 05/14/2013SE |
| K123159 | Smith & Newphew, Inc. Disposable Knee InstrumentsJWH · Traditional | 05/03/2013SE |
| K123393 | Healicoil Suture Anchor with RegenesorbMAI · Traditional | 04/11/2013SE |
| K122059 | All-Suture Anchor Twist Drill for All-Suture Anchors Inline Drill Guide for All-Suture…MBI · Traditional | 03/18/2013SE |
| K123948 | China Nails and AccessoriesJDS · Traditional | 03/14/2013SE |
| K123425 | Twinfix Ti 3.5MM Suture Anchor with Two Ultrabraid Suture #2 with Needles, SLMBI · Traditional | 02/20/2013SE |
| K123055 | Smith & Nephew, Inc Screw and Plate System InstrumentationHRS · Traditional | 01/25/2013SE |
| K123579 | Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SLMBI · Special | 01/23/2013SE |
| K122596 | Arthroscopic Surgical Instruments - Interference Screw SystemsHWC · Traditional | 11/20/2012SE |
| K123012 | Smith & Nephew SMF Hip StemLPH · Special | 10/24/2012SE |
| K122170 | Smith & Nephew, Inc. Intramedullary Nail System InstrumentationHSB · Traditional | 10/19/2012SE |
| K121861 | Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB…GAT · Traditional | 10/18/2012SE |
| K122139 | Smith & Nephew R3 Constrained LinersKWZ · Traditional | 10/16/2012SE |
| K121627 | Smith & Nephew Redapt Revision Femoral SystemMEH · Abbreviated | 10/15/2012SE |
| K113039 | Smith & Nephew Radiopaque Trial NecksMEH · Traditional | 10/05/2012SE |
| K121714 | Smith & Nephew, Inc. Shoulder System InstrumentsHSD · Traditional | 09/07/2012SE |
| K122296 | Sl-Plus Mia Femoral Stems with Ti/Ha CoatingLZO · Special | 08/28/2012SE |
| K122244 | Polarcup Dual Mobility SystemLPH · Special | 08/23/2012SE |
| K121443 | Journey II CR Knee SystemJWH · Abbreviated | 08/13/2012SE |
| K121393 | Smith & Nephew, Inc. Total Knee System InstrumentationMBH · Traditional | 08/07/2012SE |
| K120211 | Sl-Plus Standard and Lateral Femoral Stem with Ti/Ha CoatingLZO · Traditional | 07/19/2012SE |
| K121018 | Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture anMBI · Traditional | 06/22/2012SE |
| K120871 | Smith & Nephew, Inc. External Fixation System InstrumentationJDW · Traditional | 06/07/2012SE |
| K120698 | Genesis II PS Non-Modular Femoral ComponentJWH · Special | 05/18/2012SE |
| K112127 | Pico Single Use Negative Pressure Wound Therapy SystemOMP · Traditional | 05/16/2012SE |
| K113848 | R3 Xlpe LinersMBL · Traditional | 04/27/2012SE |
| K113789 | Modular Proximally Fluted Hip StemMEH · Abbreviated | 04/19/2012SE |
| K120667 | VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…HRS · Special | 04/04/2012SE |
| K113274 | Footprint Ultra PK Suture AnchorMBI · Traditional | 03/06/2012SE |
| K113482 | Journey II Deep Dished Articular InsertsJWH · Traditional | 02/27/2012SE |
| K112526 | Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra Ha Suture AnchorsMBI · Traditional | 01/31/2012SE |
| K113294 | Smith & Nephew Healicoil PK Suture AnchorMBI · Traditional | 01/20/2012SE |
| K113038 | Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System InstrumentsHSX · Traditional | 01/05/2012SE |
| K113012 | Promos Modular Shoulder SystemKWS · Traditional | 01/05/2012SE |
| K112941 | Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral ComponentsJWH · Abbreviated | 12/20/2011SE |
| K111170 | PicoOMP · Traditional | 12/15/2011SE |
| K112784 | Renasys AB Abominal Dressing KitFTL · Special | 11/22/2011SE |
| K112134 | Truclear Operative HysteroscopeHIH · Traditional | 11/22/2011SE |
| K112406 | Peri-Loc Proximal Femur Locking Bone PlatesHRS · Traditional | 11/14/2011SE |
| K110135 | Polarcup Dual Mobility SystemLPH · Traditional | 10/14/2011SE |
| K111994 | Smith & Nephew Cannulated Screws and WashersHWC · Traditional | 10/11/2011SE |
| K111711 | Journey II BCS Knee SystemJWH · Abbreviated | 09/16/2011SE |
| K111635 | Smith & Nephew RJ Constrained LinersKWZ · Traditional | 09/09/2011SE |
| K110958 | Versajet II Hydrosurgery System Console / Exact Handpieces / Plus Handpieces, Versajet…FQH · Traditional | 08/01/2011SE |
| K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…HRS · Traditional | 07/12/2011SE |
| K111025 | Trigen Low Profile Bone ScrewHSB · Traditional | 07/01/2011SE |
| K110545 | Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor (Ngftsa PK)MBI · Traditional | 06/24/2011SE |
| K110647 | Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound…OMP · Traditional | 06/22/2011SE |
| K103793 | Durafiber AGFRO · Traditional | 05/02/2011SE |
| K110837 | Revision ProthesisJWH · Special | 04/22/2011SE |
| K110240 | Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1OLO · Special | 04/14/2011SE |
| K110101 | Taper Oxinium Femoral HeadLZO · Traditional | 04/11/2011SE |
| K110038 | Truclear Morcellator SystemHIH · Special | 03/30/2011SE |
| K103389 | Truclear Incisor Plus Blade 2.9HIH · Traditional | 03/25/2011SE |
| K110069 | Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareKTT · Special | 02/08/2011SE |
| K103256 | Smith & Nephew SMF Hip StemLPH · Abbreviated | 01/31/2011SE |
| K101459 | Osteoraptor II Suture Anchor or to Be Determined Model: 72202764 72202765 72202766…MAI · Traditional | 01/27/2011SE |
| K102370 | R3 Xlpe Anteverted LinersMBL · Abbreviated | 01/19/2011SE |
| K102122 | Smith & Nephew Milti-Purpose Sterilization Tray Model 72202428KCT · Traditional | 11/22/2010SE |
| K102069 | Journey Unicondylar Tibial BaseplatesHSX · Traditional | 10/05/2010SE |
| K093047 | Smith & Nephew Circular Fixation SystemKTT · Traditional | 09/27/2010SE |
| K100787 | Renasys F/-Ab Abdominal Wound Dressing KitFTL · Traditional | 09/17/2010SE |
| K100795 | Jet-X Bar System Clamps and Posts ReprocessingKTT · Traditional | 09/02/2010SE |
| K101499 | Journey CR Knee SystemJWH · Abbreviated | 08/26/2010SE |
| K102001 | Modification to Renasys Ez Plus Negative Pressure Wound TherapyOMP · Special | 08/06/2010SE |
| K100481 | Smith & Nephew MDF Modular SleeveMEH · Abbreviated | 07/15/2010SE |
| K100897 | Legion Porous + Ha Tibial BaseplatesMBH · Special | 05/13/2010SE |
| K100412 | Biolox Delta Ceramic Femoral HeadsLZO · Traditional | 05/05/2010SE |
| K100325 | Peri-Loc Locking Hole Inserts and Cable AccessoriesHWC · Traditional | 05/04/2010SE |
| K092748 | Sureshot Tan Nails and AccessoriesHSB · Traditional | 04/26/2010SE |
| K090982 | Smith & Nephew Hip Systems with HaMEH · Abbreviated | 04/21/2010SE |
| K093991 | Slr-Plus Standard and Lateral Femoral StemsLZO · Traditional | 04/15/2010SE |
| K093746 | Verilast Wear Claims for the Legion Primary Knee SystemJWH · Traditional | 04/14/2010SE |
| K093935 | Smith & Nephew Footprint RCX PK Suture AnchorMBI · Traditional | 04/05/2010SE |
| K093844 | Smith & Nephew Twinfix Ultra Ha Suture AnchorMAI · Traditional | 04/01/2010SE |
| K100107 | Smith & Nephew Sureshot Distal Targeting System V2.0OLO · Special | 02/23/2010SE |
| K100197 | Genesis Unicondylar Uhmwpe Articular InsertsHSX · Special | 02/19/2010SE |
| K092508 | Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,Fast Fix 360 AB…GAT · Traditional | 01/28/2010SE |
| K093363 | Cocr and Oxinium Femoral Heads and R3 Xlpe LinersMBL · Traditional | 01/26/2010SE |
| K092098 | Patient Specific Acetabular Reconstruction ProsthesisLPH · Traditional | 01/22/2010SE |
| K091543 | Legion Porous Plus Ha Primary Femoral ComponentsMBH · Abbreviated | 12/21/2009SE |
| K093228 | Smith & Nephew Twinfix Ultra PK Suture AnchorMBI · Traditional | 12/15/2009SE |
| K093056 | Smith & Nephew, Inc. Journey Select Knee SystemNPJ · Traditional | 12/15/2009SE |
| K092002 | Afghan External FixatorKTT · Traditional | 12/10/2009SE |
| K092386 | R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersMBL · Abbreviated | 11/03/2009SE |
| K091014 | Journey BCS Knee SystemJWH · Traditional | 09/29/2009SE |
| K092497 | Smith & Nephew Pigalileo Screw Targeting System, Version 1.1OLO · Special | 09/11/2009SE |
| K092015 | Peri-Loc Periarticular Locked Plating SystemHRS · Special | 07/30/2009SE |
| K083113 | Acticoat Flex 7 DressingFRO · Traditional | 07/22/2009SE |
| K090955 | Smith & Nephew RF CannulateGXI · Traditional | 07/16/2009SE |
| K091470 | Ranasys Ez Negative Pressure Wound Therapy System, Model 66800059OMP · Traditional | 07/09/2009SE |
| K091627 | Smith & Nephew Instrument TraysKCT · Special | 07/02/2009SE |
| K090926 | Smith & Nephew Rail SystemKTT · Traditional | 06/08/2009SE |
| K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesHRS · Traditional | 06/04/2009SE |
| K090656 | Intertan CHS Limited Collapse Set ScrewHWC · Traditional | 06/03/2009SE |
| K090420 | Smith & Nephew Pigalileo Screw Targeting System V 1.0OLO · Abbreviated | 05/27/2009SE |
| K090562 | Smith & Nephew Instrument TraysKCT · Special | 03/18/2009SE |
| K090313 | Pigalileo TKR Base V2.3 and Cas V4.1OLO · Special | 03/11/2009SE |
| K083762 | Biolox Delta Ceramic Femoral HeadsLZO · Special | 03/11/2009SE |
| K083566 | R3 Constrained Liner, Constrained LinerKWZ · Traditional | 03/03/2009SE |
| K083375 | Renasys Go Negative Pressure Wound TherapyOMP · Traditional | 02/25/2009SE |
| K083565 | Pigalileo Total Hip Replacement (THR) Software Application V3.0HAW · Special | 02/20/2009SE |
| K082371 | Smith & Nephew Sl-Plus Mia Standard and Lateral Femoral Hip StemLZO · Traditional | 02/09/2009SE |
| K083528 | Smith & Nephew Bipolar Adapter Cable, Model 72200022GEI · Traditional | 01/28/2009SE |
| K083032 | Peri-Loc Bone Plating and Screw SystemHRS · Traditional | 01/07/2009SE |
| K082358 | Smith & Nephew, Inc. Patient Matched TechnologyJWH · Traditional | 11/25/2008SE |
| K082211 | Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsOMP · Traditional | 11/14/2008SE |
| K082267 | Pigalileo Cas, Version 4.0 and TKR Base, Version 2.1HAW · Special | 10/29/2008SE |
| K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsHWC · Special | 09/17/2008SE |
| K082426 | Renasys EzOMP · Special | 09/05/2008SE |
| K081016 | Smith & Nephew, Inc., Promos Reverse Shoulder SystemPHX · Traditional | 09/05/2008SE |
| K081511 | 2.0 PK Suture Anchor T, 2.0 PK Suture Anchor SMBI · Traditional | 08/26/2008SE |
| K081566 | Smith & Nephew Oxinium DH Femoral HeadsLPH · Special | 08/21/2008SE |
| K081124 | MDF Revision Hip SystemMEH · Abbreviated | 07/31/2008SE |
| K081351 | Modification to Journey Unicondylar Femoral ImplantHSX · Special | 07/24/2008SE |
| K081111 | Legion Hinge Knee SystemKRO · Traditional | 07/23/2008SE |
| K080875 | Pigalileo 4TH Generation SystemHAW · Abbreviated | 07/18/2008SE |
| K081491 | Smith & Nephew CDS SystemJAA · Special | 06/19/2008SE |
| K081106 | Peri-Loc Periarticular Locked Plating System Volar Distal Radius Locking Plate for the…HRS · Special | 06/18/2008SE |
| K072852 | Sl-Plus Standard and Lateral Hip StemsLZO · Traditional | 06/09/2008SE |
| K072817 | Echelon Titanium Hip SystemLPH · Traditional | 05/15/2008SE |
| K080625 | Smith & Nephew Mis Hip Stem with StiktiteLPH · Special | 05/08/2008SE |
| K080434 | Intertan CHS Locking Plate System Prox Fem Plates/ScrewJDO · Traditional | 04/10/2008SE |
| K072212 | Jet-X Bar System Clamps, Bars and Posts-Mr SafeKTT · Special | 03/07/2008SE |
| K073509 | Twinfix PK FP Suture AnchorHWC · Traditional | 03/04/2008SE |
| K073466 | Smith & Nephew Intradiscal Catheter SystemGEI · Traditional | 02/22/2008SE |
| K072417 | Smith & Nephew Mis Hip StemLPH · Abbreviated | 01/10/2008SE |
| K073325 | Legion Porous PrimaryMBH · Special | 12/20/2007SE |
| K073175 | Journey Unicondylar Femoral ImplantHSX · Abbreviated | 12/20/2007SE |
| K072531 | Legion Stem with HolesJWH · Traditional | 12/06/2007SE |
| K072858 | Tc-Plus Primary Knee SystemJWH · Abbreviated | 11/20/2007SE |
| K072818 | Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe AccessHRS · Traditional | 11/19/2007SE |
| K062607 | Polygraft BGSMQV · Traditional | 11/09/2007SESU |
| K072675 | Smith & Nephew ArthroscopeHRX · Special | 10/15/2007SE |
| K071160 | Reflection, Tandem UnipolarLPH · Traditional | 10/05/2007SE |
| K071071 | Crosslinked Polyethylene Articular InsertsJWH · Abbreviated | 09/19/2007SE |
| K072322 | Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair SystemsGAT · Special | 09/18/2007SE |
| K071790 | Genesis II Total Knee System, Legion Revision Knee System, Journey BCS Knee SystemMBH · Traditional | 08/17/2007SE |
| K071563 | Peri-Loc Periarticular Locked Plating SystemHRS · Traditional | 08/08/2007SE |
| K063835 | Allevyn AG DressingFRO · Traditional | 08/03/2007SE |
PMA approvals
- P150030 R3 Delta Ceramic Hip System · 10/17/2016 · 48 supplements
- P040033 Birmingham Hip Resurfacing (BHR) System · 05/09/2006 · 36 supplements
- P030022 Reflection Ceramic Acetabular System · 12/17/2004 · 47 supplements
- P000057 Ascension MCP · 11/19/2001 · 14 supplements
- P810048 Osteo Ceramic Hip · 11/05/1982 · 9 supplements
Recalls (latest 200)
| Recall | Product | Initiated |
|---|---|---|
| Z-2456-2026 Class II | TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision… | 03/16/2026Open, Classified |
| Z-0957-2026 Class II | BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.Removal of affected lot of screws due to labeling error. | 11/24/2025Open, Classified |
| Z-1806-2025 Class II | META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized… | 03/18/2025Open, Classified |
| Z-0581-2025 Class II | BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device. | 10/29/2024Open, Classified |
| Z-0326-2025 Class II | Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM…The Bipolar assembly contains an oversized Retainer Ring. | 10/15/2024Open, Classified |
| Z-0282-2025 Class II | smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N…Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead… | 10/02/2024Open, Classified |
| Z-0281-2025 Class II | smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT…Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead… | 10/02/2024Open, Classified |
| Z-0278-2025 Class II | smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF…Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a… | 10/02/2024Open, Classified |
| Z-0277-2025 Class II | smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF…Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a… | 10/02/2024Open, Classified |
| Z-3097-2024 Class II | ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of…Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding… | 08/12/2024Open, Classified |
| Z-3096-2024 Class II | ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of…Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding… | 08/12/2024Open, Classified |
| Z-3172-2024 Class II | DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastenerSmith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a… | 07/09/2024Open, Classified |
| Z-3171-2024 Class II | DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastenerSmith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a… | 07/09/2024Open, Classified |
| Z-1901-2024 Class II | smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and…Packaging contained the incorrect size of femoral head from what was displayed on the label. | 04/24/2024Open, Classified |
| Z-0158-2024 Class II | JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee…The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD… | 09/27/2023Open, Classified |
| Z-0157-2024 Class II | JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesisThe JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD… | 09/27/2023Open, Classified |
| Z-2621-2023 Class II | smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N…The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW… | 08/31/2023Open, Classified |
| Z-2444-2023 Class II | TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340…A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME… | 07/24/2023Open, Classified |
| Z-2443-2023 Class II | TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336…A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME… | 07/24/2023Open, Classified |
| Z-1673-2023 Class II | Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers:…Recent complaint data indicates that the revision rate may be trending higher than corresponding similar… | 05/02/2023Open, Classified |
| Z-1672-2023 Class II | Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a)…Recent complaint data indicates that the revision rate may be trending higher than corresponding similar… | 05/02/2023Open, Classified |
| Z-1671-2023 Class II | Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a)…Recent complaint data indicates that the revision rate may be trending higher than corresponding similar… | 05/02/2023Open, Classified |
| Z-1670-2023 Class II | Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part…Recent complaint data indicates that the revision rate may be trending higher than corresponding similar… | 05/02/2023Open, Classified |
| Z-1393-2023 Class II | JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MMA mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II… | 03/27/2023Open, Classified |
| Z-1418-2022 Class II | (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis…The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not… | 06/27/2022Terminated |
| Z-1099-2022 Class II | LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN… | 04/19/2022Terminated |
| Z-0548-2022 Class II | INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 NDThe affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw | 01/04/2022Open, Classified |
| Z-0635-2022 Class II | Acufex Access Advanced Positioning Kit - indicated for use to position and distract the…Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did… | 12/14/2021Open, Classified |
| Z-0366-2022 Class II | smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports… | 11/01/2021Terminated |
| Z-0365-2022 Class II | smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports… | 11/01/2021Terminated |
| Z-0364-2022 Class II | smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports… | 11/01/2021Terminated |
| Z-0363-2022 Class II | smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports… | 11/01/2021Terminated |
| Z-0265-2022 Class II | Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and…The labels on the packages of screws were switched. | 10/25/2021Open, Classified |
| Z-0143-2022 Class II | 6.5MMX165MM CANNULATED SCREWThe product label incorrectly indicated that the screws are fully threaded, but the screws contained in the… | 09/20/2021Terminated |
| Z-1951-2021 Class II | LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left…The device components experienced a manufacturing process error that resulted in surface damage from product… | 05/19/2021Terminated |
| Z-1510-2021 Class II | CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference…Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw | 04/08/2021Terminated |
| Z-0933-2021 Class II | VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number:…Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy… | 12/18/2020Terminated |
| Z-0772-2021 Class II | Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the…Manufacturing packaging error. | 11/02/2020Terminated |
| Z-0301-2021 Class II | 5.5MM Arthrogarde Hip Access CannulaThe J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking… | 09/21/2020Terminated |
| Z-0118-2021 Class II | Genesis (GII) - Product Usage: designed for use in patients in primary and revision…The anterior locking detail does not meet its design specifications. | 09/21/2020Terminated |
| Z-0175-2021 Class II | MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0174-2021 Class II | MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0173-2021 Class II | HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0172-2021 Class II | HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number:…Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0171-2021 Class II | HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number:…Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0170-2021 Class II | HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0169-2021 Class II | HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number:…Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0168-2021 Class II | HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number:…Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0167-2021 Class II | HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number:…Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0166-2021 Class II | OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0165-2021 Class II | OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0164-2021 Class II | TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number:…Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0163-2021 Class II | TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0162-2021 Class II | TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0161-2021 Class II | TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0160-2021 Class II | TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0159-2021 Class II | TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0158-2021 Class II | TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0157-2021 Class II | TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0156-2021 Class II | TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0155-2021 Class II | TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0154-2021 Class II | OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0153-2021 Class II | OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0152-2021 Class II | OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0151-2021 Class II | OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0150-2021 Class II | OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0149-2021 Class II | OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0148-2021 Class II | OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0147-2021 Class II | RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0146-2021 Class II | BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0145-2021 Class II | ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0144-2021 Class II | ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0143-2021 Class II | ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0142-2021 Class II | TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0141-2021 Class II | TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0140-2021 Class II | TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number:…Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0139-2021 Class II | TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0138-2021 Class II | TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0137-2021 Class II | TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0136-2021 Class II | TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-2945-2020 Class II | EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for…Multiple or incorrect expiration dates were provided on the affected designation labels. | 08/24/2020Terminated |
| Z-2818-2020 Class II | Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to…The products were improperly heat treated. | 08/03/2020Open, Classified |
| Z-2774-2020 Class II | Tibial knee prosthesisDue to an inconsistency in the raw material process, specific lots may contain units with internal… | 07/16/2020Open, Classified |
| Z-2777-2020 Class II | PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used…The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part. | 06/29/2020Terminated |
| Z-2746-2020 Class II | SUTUREFIX ULTRA Suture, Product number 72203855A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one… | 06/24/2020Open, Classified |
| Z-2702-2020 Class II | Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated…The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended… | 06/24/2020Open, Classified |
| Z-2685-2020 Class II | TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw…A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene… | 06/24/2020Terminated |
| Z-2336-2020 Class II | smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured…A manufacturing error resulted in out of specification R3 Acetabular Shells | 04/22/2020Open, Classified |
| Z-2335-2020 Class II | smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the…A manufacturing error resulted in out of specification R3 Acetabular Shells | 04/22/2020Open, Classified |
| Z-2334-2020 Class II | smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured…A manufacturing error resulted in out of specification R3 Acetabular Shells | 04/22/2020Open, Classified |
| Z-2333-2020 Class II | smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the…A manufacturing error resulted in out of specification R3 Acetabular Shells | 04/22/2020Open, Classified |
| Z-2332-2020 Class II | smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in…A manufacturing error resulted in out of specification R3 Acetabular Shells | 04/22/2020Open, Classified |
| Z-2331-2020 Class II | smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the…A manufacturing error resulted in out of specification R3 Acetabular Shells | 04/22/2020Open, Classified |
| Z-1757-2020 Class II | Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902Space between the device and the packaging permits excessive movement which could potentially lead to the… | 03/17/2020Open, Classified |
| Z-1756-2020 Class II | Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901Space between the device and the packaging permits excessive movement which could potentially lead to the… | 03/17/2020Open, Classified |
| Z-1634-2020 Class II | NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is…Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when… | 02/27/2020Terminated |
| Z-2133-2020 Class II | JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The…The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to… | 01/28/2020Terminated |
| Z-2132-2020 Class II | JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The…The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to… | 01/28/2020Terminated |
| Z-1273-2020 Class II | TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to…Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube… | 12/30/2019Terminated |
| Z-1507-2020 Class II | LEGION PS High Flex XLPE size 5-6 9mm Articular InsertLEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part | 12/19/2019Terminated |
| Z-0878-2020 Class II | LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF…Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and… | 12/16/2019Open, Classified |
| Z-0696-2020 Class II | smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet…There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the… | 11/11/2019Terminated |
| Z-0351-2020 Class II | LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN…LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls in the… | 10/07/2019Terminated |
| Z-1029-2019 Class II | smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM…Complaints were received indicating that the outer label incorrectly identified the product as size "1"… | 02/19/2019Terminated |
| Z-1028-2019 Class II | smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM…Complaints were received indicating that the outer label incorrectly identified the product as size "1"… | 02/19/2019Terminated |
| Z-0730-2019 Class II | SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble. | 01/07/2019Terminated |
| Z-1045-2019 Class II | JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial…Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch | 12/10/2018Terminated |
| Z-1044-2019 Class II | JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNEY II XR Tibial…Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch | 12/10/2018Terminated |
| Z-1043-2019 Class II | JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial…Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch | 12/10/2018Terminated |
| Z-1042-2019 Class II | JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 The JOURNEY II XR Tibial…Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch | 12/10/2018Terminated |
| Z-0200-2019 Class II | Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411…One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring. | 09/18/2018Terminated |
| Z-0003-2019 Class II | JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113…The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian… | 06/13/2018Open, Classified |
| Z-0002-2019 Class II | JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111…The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian… | 06/13/2018Open, Classified |
| Z-0001-2019 Class II | Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212…The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian… | 06/13/2018Open, Classified |
| Z-2268-2018 Class II | Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156…The affected devices are manufactured to the same design specification as products intended for sale and use… | 05/11/2018Terminated |
| Z-2267-2018 Class II | Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm…The affected devices are manufactured to the same design specification as products intended for sale and use… | 05/11/2018Terminated |
| Z-2163-2018 Class II | smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification. | 05/04/2018Terminated |
| Z-1921-2018 Class II | smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM…Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device… | 05/02/2018Terminated |
| Z-1902-2018 Class II | smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The…A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error. The left… | 04/09/2018Terminated |
| Z-1907-2018 Class II | smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF…The affected products were inadvertently packaged with the inner packaging pouch being sealed together with… | 03/30/2018Terminated |
| Z-1906-2018 Class II | smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF…The affected products were inadvertently packaged with the inner packaging pouch being sealed together with… | 03/30/2018Terminated |
| Z-1905-2018 Class II | smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF…The affected products were inadvertently packaged with the inner packaging pouch being sealed together with… | 03/30/2018Terminated |
| Z-1904-2018 Class II | smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF…The affected products were inadvertently packaged with the inner packaging pouch being sealed together with… | 03/30/2018Terminated |
| Z-1317-2018 Class II | D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the…One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of… | 03/07/2018Terminated |
| Z-1105-2018 Class II | smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159…The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used… | 02/01/2018Terminated |
| Z-2538-2019 Class II | LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432…The affected products were inadvertently packaged with an incorrect screw component. | 01/15/2018Completed |
| Z-0409-2018 Class II | Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A…In rare circumstances, when surgeons use the software to plan the strut adjustment, an inverted image of the… | 12/13/2017Terminated |
| Z-1536-2018 Class II | Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of… | 12/11/2017Terminated |
| Z-0397-2018 Class II | smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System…Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM… | 12/11/2017Terminated |
| Z-0396-2018 Class II | smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System…Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM… | 12/11/2017Terminated |
| Z-0408-2018 Class II | smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N…One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates. | 11/29/2017Terminated |
| Z-0097-2018 Class II | smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET…A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down. | 10/24/2017Open, Classified |
| Z-0406-2018 Class II | Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.The expiration date provided on the label is incorrect. | 10/23/2017Terminated |
| Z-0092-2018 Class II | smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF…The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw. | 09/14/2017Terminated |
| Z-2883-2018 Class II | GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026…Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II… | 08/01/2017Terminated |
| Z-3100-2017 Class II | smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and…The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple… | 07/24/2017Terminated |
| Z-2625-2017 Class II | LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c)…The incorrect Loctite adhesive was used to assemble the impactor heads. | 05/30/2017Terminated |
| Z-2624-2017 Class II | LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c)…The incorrect Loctite adhesive was used to assemble the impactor heads. | 05/30/2017Terminated |
| Z-1920-2017 Class II | RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |
| Z-1919-2017 Class II | RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |
| Z-1918-2017 Class II | RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |
| Z-1917-2017 Class II | RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |
| Z-1916-2017 Class II | RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |
| Z-1915-2017 Class II | RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |
| Z-1914-2017 Class II | RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |
| Z-1913-2017 Class II | RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |
| Z-1912-2017 Class II | RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |
| Z-1911-2017 Class II | RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |
| Z-1910-2017 Class II | RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |
| Z-1909-2017 Class II | RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |
| Z-2036-2017 Class II | PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE…This lot of left plates were laser etched and packaged as right plates. | 03/22/2017Terminated |
| Z-1851-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 12MM Product Number: 72204050 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1850-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11.5MM Product Number: 72204049 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1849-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number: 72204048 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1848-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10.5MM Product Number: 72204047 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1847-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10MM Product Number: 72204046 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1846-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9.5MM Product Number: 72204045 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1845-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9MM Product Number: 72204044 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1844-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 72204043 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1843-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM Product Number: 72204042 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1842-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7.5MM Product Number: 72204041 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1841-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7MM Product Number: 72204040 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1840-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM Product Number: 72204039 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1839-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6MM Product Number: 72204038 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1838-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM Product Number: 72204037 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1857-2017 Class II | D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X…The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the… | 03/09/2017Terminated |
| Z-1856-2017 Class II | D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 OrthopedicThe expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the… | 03/09/2017Terminated |
| Z-1855-2017 Class II | D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 OrthopedicThe expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the… | 03/09/2017Terminated |
| Z-1854-2017 Class II | Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF…The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the… | 03/09/2017Terminated |
| Z-1244-2017 Class II | Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706The single use devices are provided sterile and do not have an expiration date on the label. | 02/02/2017Terminated |
| Z-1243-2017 Class II | Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705The single use devices are provided sterile and do not have an expiration date on the label. | 02/02/2017Terminated |
| Z-1242-2017 Class II | Smith & Nephew Dyonics Saw Blade, Short, Narrow, Product Number 3704The single use devices are provided sterile and do not have an expiration date on the label. | 02/02/2017Terminated |
| Z-1241-2017 Class II | Smith & Nephew Dyonics Saw Blade, Short, Product Number 3703The single use devices are provided sterile and do not have an expiration date on the label. | 02/02/2017Terminated |
| Z-1240-2017 Class II | Smith & Nephew Dyonics Saw Blade, Standard, Thick, Product Number 3702The single use devices are provided sterile and do not have an expiration date on the label. | 02/02/2017Terminated |
| Z-1239-2017 Class II | Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701The single use devices are provided sterile and do not have an expiration date on the label. | 02/02/2017Terminated |
| Z-1008-2017 Class II | REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew…The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of… | 11/16/2016Terminated |
| Z-0946-2017 Class II | Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for…All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and… | 11/15/2016Terminated |
| Z-0945-2017 Class II | Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for…All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and… | 11/15/2016Terminated |
| Z-0944-2017 Class II | Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems…All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and… | 11/15/2016Terminated |
| Z-1042-2017 Class II | Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit…Lack of 510k clearance for design modification. | 11/11/2016Open, Classified |
| Z-1041-2017 Class II | Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for…Lack of 510k clearance for design modification. | 11/11/2016Open, Classified |
| Z-0351-2017 Class II | TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039…Some Bipolar shells were manufactured with an out of specification retainer groove. | 08/29/2016Terminated |
| Z-0350-2017 Class II | TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042…Some Bipolar shells were manufactured with an out of specification retainer groove. | 08/29/2016Terminated |
| Z-2848-2016 Class II | RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the…Sterility seal integrity failures on the Renasys Sterile Transparent Film | 07/21/2016Open, Classified |
| Z-2745-2016 Class II | Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during…Sterility compromised due to breach in sterile packaging | 07/19/2016Terminated |
| Z-2297-2016 Class II | SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R…The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm… | 07/06/2016Terminated |
| Z-2218-2016 Class II | Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for…The device could be subject to breaches of its sterile packaging. | 06/15/2016Terminated |
| Z-2095-2016 Class II | LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365 The…The surface inside of the femoral component, where cement is applied for adhesion, is below specification. | 05/26/2016Terminated |
| Z-2094-2016 Class II | LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 The…The surface inside of the femoral component, where cement is applied for adhesion, is below specification. | 05/26/2016Terminated |
| Z-2093-2016 Class II | LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364 The…The surface inside of the femoral component, where cement is applied for adhesion, is below specification. | 05/26/2016Terminated |
| Z-2092-2016 Class II | LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 71421374 The…The surface inside of the femoral component, where cement is applied for adhesion, is below specification. | 05/26/2016Terminated |
| Z-2091-2016 Class II | LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 The…The surface inside of the femoral component, where cement is applied for adhesion, is below specification. | 05/26/2016Terminated |
| Z-2090-2016 Class II | LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The…The surface inside of the femoral component, where cement is applied for adhesion, is below specification. | 05/26/2016Terminated |
| Z-1551-2016 Class II | TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12…The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being… | 03/11/2016Terminated |
| Z-1550-2016 Class II | TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12…The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being… | 03/11/2016Terminated |
| Z-1549-2016 Class II | TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12…The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being… | 03/11/2016Terminated |
| Z-1548-2016 Class II | TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12…The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being… | 03/11/2016Terminated |
| Z-1547-2016 Class II | TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 4 RIGHT, STERILE R, REF 12…The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being… | 03/11/2016Terminated |
| Z-1546-2016 Class II | TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000…The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being… | 03/11/2016Terminated |
| Z-1545-2016 Class II | TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R, REF 12 000…The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being… | 03/11/2016Terminated |