Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
FDA product code KWA · Class III (high risk) · 21 CFR 888.3330 · Orthopedic
114510(k) clearances
0PMA approvals
202recalls
Implantimplanted device
Manufacturers
- Wrightmedicaltechnologyinc 26
- Biomet Manufacturing Corp 14
- DePuy Orthopaedics, Inc. 12
- Biomet, Inc. 11
- Zimmer, Inc. 9
- Encore Medical L.P. 5
- Protek, Inc. 4
- Advanced Biosearch Assn. 3
- Allo Pro Corp. 3
- Osteonics Corp. 3
- Sulzer Orthopedics, Inc. 3
- Downs Surgical , Ltd. 2
- Centerpulse Orthopedics, Inc. 2
- Turnkey Intergration USA, Inc. 2
- Waldemar Link GmbH & Co. KG 2
- American Ortomed Corp. 2
- Synergy Orthopaedics Intl., Inc. 1
- Kinamed, Inc. 1
- Kirschner Medical Corp. 1
- Encore Medical, Lp 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K122778 | Profemur Z Revision Hip StemKWA · Special | Wrightmedicaltechnologyinc | 10/11/2012SE |
| K121544 | Dynasty Biofoam ShellKWA · Traditional | Wrightmedicaltechnologyinc | 07/30/2012SE |
| K113271 | Metal-On-Metal Hip Systems-Additional ContraindicationsKWA · Traditional | Biomet Manufacturing, Inc. | 05/18/2012SE |
| K113322 | Conserve Thin ShellKWA · Special | Wrightmedicaltechnologyinc | 02/03/2012SE |
| K112080 | Preserve Hip StemKWA · Special | Wrightmedicaltechnologyinc | 12/28/2011SE |
| K112150 | Profemur Gladiator Ha Hip StemKWA · Traditional | Wrightmedicaltechnologyinc | 11/23/2011SE |
| K113019 | Profemur XM Wingless Distal Centralizer, Perfecta Distal CentralizerKWA · Special | Wrightmedicaltechnologyinc | 11/10/2011SE |
| K111910 | Gladiator Hip StemKWA · Traditional | Wrightmedicaltechnologyinc | 10/14/2011SE |
| K110836 | CLS Brevius Stem with Kinectiv TechnologyKWA · Traditional | Zimmer GmbH | 10/07/2011SE |
| K110400 | Taperloc Complete Microplasty StemKWA · Traditional | Biomet Manufacturing Corp | 09/30/2011SE |
| K111699 | Profemur(R) Z Titanium Plasma Sprayed Hip StemKWA · Special | Wrightmedicaltechnologyinc | 08/19/2011SE |
| K111698 | Profemur(R) E Cementless Hip StemKWA · Special | Wrightmedicaltechnologyinc | 08/19/2011SE |
| K110399 | Gladiator Plasma Classic Hip StemKWA · Traditional | Wrightmedicaltechnologyinc | 05/10/2011SE |
| K110029 | Conserve Bio Foam ShellKWA · Traditional | Wrightmedicaltechnologyinc | 04/19/2011SE |
| K103755 | Taperloc Complete, Size 5 and 6KWA · Special | Biomet Manufacturing Corp | 01/21/2011SE |
| K102565 | Anterior Approach Hip Surgery InstrumentsKWA · Special | Wrightmedicaltechnologyinc | 12/22/2010SE |
| K100469 | Arcos Interlocking Distal StemsKWA · Traditional | Biomet Manufacturing Corp | 12/07/2010SE |
| K101086 | Taperloc CompleteKWA · Traditional | Biomet, Inc. | 09/03/2010SE |
| K101475 | Compress Anti-Rotation SpindlesKWA · Special | Biomet Manufacturing Corp | 06/18/2010SE |
| K093235 | Ringloc + Hybrid Acetabular SystemKWA · Traditional | Biomet, Inc. | 04/30/2010SE |
| K092331 | Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;KWA · Traditional | Encore Medical L.P. | 03/03/2010SE |
| K091003 | Zimmer MMC CupKWA · Traditional | Zimmer GmbH | 11/24/2009SE |
| K091973 | Metasul Taper Liners, Metasul Femoral HeadsKWA · Traditional | Zimmer GmbH | 11/17/2009SE |
| K090757 | Biomet Modular Femoral Revision SystemKWA · Traditional | Biomet, Inc. | 09/25/2009SE |
| K091423 | Profemur Hip System Modular NecksKWA · Traditional | Wrightmedicaltechnologyinc | 08/25/2009SE |
| K083651 | Revelation Stem, Model 427-21/42-080/180KWA · Special | Encore Medical L.P. | 03/13/2009SE |
| K083642 | Depuy Pinnacle Metal-On-Metal Acetabular Cup LinersKWA · Traditional | DePuy Orthopaedics, Inc. | 03/06/2009SE |
| K082924 | Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal…KWA · Special | Wrightmedicaltechnologyinc | 03/06/2009SE |
| K082585 | Depuy Asphere M-Spec HeadKWA · Special | DePuy Orthopaedics, Inc. | 12/04/2008SE |
| K082446 | Biomet Metal-On-Metal Hip Systems- Expanded ContraindicationsKWA · Traditional | Biomet, Inc. | 10/15/2008SE |
| K080991 | Depuy Asr XL Modular Acetabular Cup SystemKWA · Traditional | DePuy Orthopaedics, Inc. | 07/02/2008SE |
| K081090 | Profemur LX 5/8 Coated Hip StemKWA · Special | Wrightmedicaltechnologyinc | 05/15/2008SE |
| K081007 | Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology SystemKWA · Special | Zimmer, Inc. | 05/06/2008SE |
| K080663 | Profemur LX Revision 5/8 Coated Hip StemKWA · Special | Wrightmedicaltechnologyinc | 04/08/2008SE |
| K073637 | Parallel-Sided Extensively Coated Femoral StemsKWA · Traditional | Biomet Manufacturing Corp | 03/20/2008SE |
| K071723 | Zimmer Porolock Mis StemKWA · Traditional | Zimmer GmbH | 03/07/2008SE |
| K073413 | Depuy Asr 300 Acetabular Cup SystemKWA · Special | DePuy Orthopaedics, Inc. | 01/30/2008SE |
| K071856 | Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model(S) 7848 Series(…KWA · Special | Zimmer, Inc. | 07/30/2007SE |
| K070221 | FMP Metal/Metal Acetabular Insert, 499-28,449-34, 499-38KWA · Traditional | Encore Medical L.P. | 04/04/2007SE |
| K070274 | Echo Bi-Metric Press-Fit StemsKWA · Special | Biomet Manufacturing Corp | 04/03/2007SE |
| K062994 | Lateralized Taperloc Microplasty Femoral ComponentsKWA · Special | Biomet Manufacturing Corp | 03/09/2007SE |
| K070359 | Depuy Asr Taper Sleeve AdapterKWA · Special | DePuy Orthopaedics, Inc. | 03/06/2007SE |
| K063614 | Altra FX Hip SystemKWA · Traditional | Biomet Manufacturing Corp | 02/20/2007SE |
| K063251 | Zimmer M/L Taper Hip Prosthesis with Modular Neck TechnologyKWA · Traditional | Zimmer, Inc. | 01/24/2007SE |
| K062998 | Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug)KWA · Traditional | Biomet Manufacturing Corp | 01/19/2007SE |
| K062426 | Depuy Pinnacle Metal-On-Metal Acetabular Cup LinersKWA · Special | DePuy Orthopaedics, Inc. | 12/15/2006SE |
| K063414 | Modification to: FMP Metal/Metal Acetabular Insert, Models 499-28, 499-34, 499-38KWA · Special | Encore Medical L.P. | 12/12/2006SE |
| K063002 | Altra Press-Fit Hip SystemKWA · Special | Biomet Manufacturing Corp | 10/31/2006SE |
| K062995 | M2A-MAGNUM Tri-Spike Acetabular ComponentKWA · Special | Biomet Manufacturing Corp | 10/31/2006SE |
| K061221 | Dupuy S-Rom STD Hip Stem ProsthesisKWA · Special | DePuy Orthopaedics, Inc. | 08/28/2006SE |
| K061423 | M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsKWA · Traditional | Biomet Manufacturing Corp | 07/27/2006SE |
| K060358 | Profemur TL Hip StemKWA · Special | Wrightmedicaltechnologyinc | 05/10/2006SE |
| K060356 | Conserve Plus Quadrafix Acetabular ShellKWA · Special | Wrightmedicaltechnologyinc | 04/18/2006SE |
| K053536 | Durom Acetabular Component and Metasul LDH Large Diameter HeadsKWA · Traditional | Zimmer GmbH | 03/16/2006SE |
| K052915 | Profemur XTR Hip StemKWA · Special | Wrightmedicaltechnologyinc | 01/27/2006SE |
| K053588 | Profemur LX Hip StemKWA · Special | Wrightmedicaltechnologyinc | 01/13/2006SE |
| K052320 | Encore CLP Offset Total Hip SystemKWA · Traditional | Encore Medical Corporation | 12/30/2005SE |
| K052888 | Porous Titanium Acetabular AugmentsKWA · Traditional | Biomet Manufacturing Corp | 12/06/2005SE |
| K050124 | Porous Coated Acetabular ComponentsKWA · Traditional | Biomet, Inc. | 10/04/2005SE |
| K043099 | Lineage Ha Acetabular ShellsKWA · Traditional | Wrightmedicaltechnologyinc | 09/29/2005SE |
| K043547 | Compress Segmental Femoral Replacement SystemKWA · Traditional | Biomet, Inc. | 08/05/2005SE |
| K040627 | Depuy Asr Modular Acetabular Cup SystemKWA · Traditional | DePuy Orthopaedics, Inc. | 08/05/2005SE |
| K050251 | Balance Hip SystemKWA · Traditional | Biomet, Inc. | 05/27/2005SE |
| K043073 | Procotyl-E Acetabular SystemKWA · Traditional | Wrightmedicaltechnologyinc | 05/04/2005SE |
| K042530 | Conserve Plus Ha Acetabular ShellsKWA · Special | Wrightmedicaltechnologyinc | 12/17/2004SE |
| K040354 | Metal/Metal Hip SystemKWA · Special | Encore Medical L.P. | 11/04/2004SE |
| K033943 | Alpha Metasul 28MM and 32MM Acetabular Inserts, Standard and HoodedKWA · Traditional | Centerpulse Orthopedics, Inc. | 10/18/2004SE |
| K042037 | M2A Magnum SystemKWA · Traditional | Biomet, Inc. | 10/01/2004SE |
| K033634 | Epsilon Metasul 32MM Acetabular Inserts, Standard and HoodedKWA · Traditional | Centerpulse Orthopedics, Inc. | 09/15/2004SE |
| K041425 | Conserve Plus Revision Shell and Conserve Plus Thick ShellKWA · Special | Wrightmedicaltechnologyinc | 06/25/2004SE |
| K031963 | Conserve Plus Spiked Acetabular Shells and Conserve Total 56MM Femoral HeadKWA · Special | Wrightmedicaltechnologyinc | 10/31/2003SE |
| K023786 | Depuy Pinnacle Metal-On-Metal Acetabular Cup LinerKWA · Special | DePuy Orthopaedics, Inc. | 12/10/2002SE |
| K021349 | Metal Transcend Articulation System (Larger Sizes)KWA · Abbreviated | Wrightmedicaltechnologyinc | 07/01/2002SE |
| K011110 | M2A Acetabular SystemKWA · Traditional | Biomet, Inc. | 07/02/2001SE |
| K003758 | Allofit Acetabular SystemKWA · Traditional | Sulzer Orthopedics, Inc. | 03/07/2001SE |
| K003250 | FMP Metal/Metal Acetabular InsertKWA · Traditional | Encore Orthopedics, Inc. | 01/25/2001SE |
| K003523 | Depuy Pinnacle Metal-On-Metal Acetabular Cup LinersKWA · Special | DePuy Orthopaedics, Inc. | 12/13/2000SE |
| K002883 | Pinnacle Metal-On-Metal Acetabular Cup LinersKWA · Special | DePuy Orthopaedics, Inc. | 10/13/2000SE |
| K002379 | M2A 28MM Ringloc LinerKWA · Special | Biomet, Inc. | 08/31/2000SE |
| K001523 | Ultima Metal-On-Metal Acetabular CupKWA · Traditional | DePuy Orthopaedics, Inc. | 08/10/2000SE |
| K001536 | Inter-Op Metasul Hooded and Protrusio Acetabular InsertsKWA · Traditional | Sulzer Orthopedics, Inc. | 07/27/2000SE |
| K993438 | Metal on Metal Acetabular SystemKWA · Traditional | Biomet, Inc. | 05/18/2000SE |
| K993569 | Apr Metasul Acetabular InsertKWA · Special | Sulzermedica | 12/01/1999SE |
| K974728 | Inter-Op Metasul Acetabular SystemKWA · Traditional | Sulzer Orthopedics, Inc. | 08/03/1999SE |
| K922868 | Thompson Type Hip ProthesisKWA · Traditional | Osteo Technology, Inc. | 02/12/1993SE |
| K902111 | Modified Freeman Revision Acetabular CupKWA · Traditional | Turnkey Intergration USA, Inc. | 08/22/1990SE |
| K902110 | Modified Freeman Acetabular CupKWA · Traditional | Turnkey Intergration USA, Inc. | 08/22/1990SE |
| K901626 | H.N. Metal Backed Acetabular Cup, NoncementedKWA · Traditional | Med-Tek Corp. | 08/14/1990SE |
| K895157 | S.A.F. Acetabular CupKWA · Traditional | Synergy Orthopaedics Intl., Inc. | 12/01/1989SE |
| K885049 | Rs-Cup Acetabular ProsthesisKWA · Traditional | Allo Pro Corp. | 01/13/1989SE |
| K882671 | Samuelson Screwloc CupKWA · Traditional | Protek, Inc. | 10/20/1988SE |
| K882675 | Ath Metal:Uhmwpe Total Hip SystemKWA · Traditional | Kinamed, Inc. | 08/19/1988SN |
| K872768 | Omniflex Normalized Hip Stem for Press-Fit Fixat.KWA · Traditional | Osteonics Corp. | 01/14/1988SE |
| K872985 | Samuelson Acetabular CupKWA · Traditional | Protek, Inc. | 10/01/1987SE |
| K870924 | CLX Acetabular Cup (Wagner) for Cementless Fixat.KWA · Traditional | Protek, Inc. | 09/14/1987SE |
| K870923 | Schuster Acetabular Cup for Cement/Cementless Fix.KWA · Traditional | Protek, Inc. | 09/14/1987SE |
| K871453 | Zweymueller-Sl Hip Prosthesis StemKWA · Traditional | Allo Pro Corp. | 07/13/1987SE |
| K871956 | Modular Range of Ring Pros. for Hip ReplacementKWA · Traditional | Downs Surgical , Ltd. | 06/23/1987SE |
| K864515 | Ring Upm Total Hip ReplacementKWA · Traditional | Downs Surgical , Ltd. | 03/13/1987SE |
| K861723 | (Modified) Omnifit Threaded Acetabular ComponentKWA · Traditional | Osteonics Corp. | 06/09/1986SE |
| K852699 | Freeman Acetabular CupKWA · Traditional | Advanced Biosearch Assn. | 09/05/1985SE |
| K852351 | Kirschner Self-Tapping Acetabular CupKWA · Traditional | Kirschner Medical Corp. | 08/09/1985SE |
| K850840 | Howmedica Threaded Acetabular ComponentKWA · Traditional | Pfizer, Inc. | 07/15/1985SE |
| K851404 | Omnifit Threaded Acetabular Components 2005 SeriesKWA · Traditional | Osteonics Corp. | 06/18/1985SE |
| K843950 | Link Cementless Screw-In Acetabular CupKWA · Traditional | Waldemar Link GmbH & Co. KG | 06/03/1985SE |
| K843940 | Link Cementless Screw-In Acetabular CupKWA · Traditional | Waldemar Link GmbH & Co. KG | 06/03/1985SE |
| K851213 | Zweymuller CupKWA · Traditional | Allo Pro Corp. | 05/28/1985SE |
| K850773 | PM Cementless Screw-In Acetabular CupKWA · Traditional | Advanced Biosearch Assn. | 05/02/1985SE |
| K850766 | Zimmer Threaded Acetabular CupKWA · Traditional | Zimmer, Inc. | 05/01/1985SE |
| K850055 | Profile Femoral HipKWA · Traditional | Depuy, Inc. | 04/23/1985SE |
| K844943 | Weill Cementless Threaded Acetabular CupKWA · Traditional | Advanced Biosearch Assn. | 03/18/1985SE |
| K842518 | Uniloc-Cementless & Self Tap AcetabularKWA · Traditional | American Ortomed Corp. | 01/30/1985SE |
| K842466 | Titanium Mittelmeier Type AcetabularKWA · Traditional | American Ortomed Corp. | 01/30/1985SE |
| K780330 | Total Hip, Lord MadreporicKWA · Traditional | Howmedica Corp. | 05/12/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 10/09/2023Open, Classified |
| Z-2605-2023 Class II | DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF:…Orthopedic device components were not subjected to final sterilization before shipment, which if implanted… | Encore Medical, LP | 08/04/2023Open, Classified |
| 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 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… | Biomet, Inc. | 06/02/2021Terminated |
| Z-0802-2021 Class II | Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058…Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter", which could lead the… | DePuy Orthopaedics, Inc. | 12/15/2020Terminated |
| Z-0335-2020 Class II | Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 00877004003…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Zimmer Biomet, Inc. | 10/10/2019Terminated |
| Z-0334-2020 Class II | Metasul Taper Liner, various sizes, Item Nos. 00877000528 00877000628 00877000732…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Zimmer Biomet, Inc. | 10/10/2019Terminated |
| Z-0642-2019 Class II | Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress…Correction to update the surgical technique for the Compress System. To make users aware of the changes that… | Zimmer Biomet, Inc. | 10/12/2018Terminated |
| Z-2821-2018 Class II | ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number…Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled.… | Zimmer Biomet, Inc. | 06/08/2018Terminated |
| Z-0300-2018 Class II | ECHO POR FMRL NC 9X125, model # 192009Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and… | Zimmer Biomet, Inc. | 06/05/2017Terminated |
| Z-1191-2017 Class II | LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision…Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal and… | Encore Medical, Lp | 01/10/2017Terminated |
| Z-0850-2016 Class II | Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads…LDPE bag containing the implant adheres to the highly polished implant surface. | Zimmer Biomet, Inc. | 01/11/2016Terminated |
| Z-1699-2015 Class I | M/L Taper with Kinectiv Technology. prosthesis, hip, semi-constrained (metal uncemented…Zimmer is initiating a voluntary recall of 64 lots (752 implants total) of M/L Taper with Kinectiv femoral… | Zimmer, Inc. | 05/18/2015Terminated |
| Z-1123-2015 Class II | Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell… | Biomet, Inc. | 01/09/2015Terminated |
| Z-1136-2015 Class II | Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient…Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may… | Zimmer Gmbh | 12/17/2014Terminated |
| Z-1133-2015 Class II | Metasul Femoral Head - A modular head component is used in conjunction with a femoral…Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may… | Zimmer Gmbh | 12/17/2014Terminated |
| Z-2084-2014 Class II | RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM…The product can be difficult to remove from the Distal Stem both out of the package and after proximal… | DePuy Orthopaedics, Inc. | 06/03/2014Terminated |