Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
FDA product code KWS · Class II (moderate risk) · 21 CFR 888.3660 · Orthopedic
191510(k) clearances
0PMA approvals
145recalls
Implantimplanted device
Manufacturers
- Tornier, Inc. 24
- Arthrex, Inc. 15
- Smith & Nephew, Inc. 11
- Encore Medical L.P. 9
- DePuy Orthopaedics, Inc. 9
- Exactech, Inc. 8
- Lima Corporate S.P.A. 8
- Tornier S.A.S. 8
- Osteonics Corp. 7
- Zimmer, Inc. 7
- Materialise NV 5
- Stryker Corporation 5
- Sulzer Orthopedics, Inc. 5
- Custom Orthopaedic Solutions, Inc. 4
- Biomet, Inc. 4
- Howmedica Osteonics Corp. 4
- Intermedics Orthopedics 4
- Encore Orthopedics, Inc. 3
- Shoulder Innovations, Inc. 3
- Ascension Orthopedics, Inc. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260721 | Tornier Perform Advanced GlenoidKWS · Traditional | Tornier, Inc. | 07/22/2026SE |
| K254084 | AETOS Shoulder System - CONCELOC GlenoidsKWS · Traditional | Smith & Nephew, Inc. | 04/06/2026SE |
| K252418 | Catalyst F1x Shoulder SystemKWS · Traditional | Catalyst Orthoscience, Inc. | 11/06/2025SE |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0KWS · Traditional | Smith & Nephew, Inc. | 10/29/2025SE |
| K241292 | MyShoulder Planner (5.3SSWPL)KWS · Traditional | Medacta International S.A. | 01/30/2025SE |
| K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…KWS · Traditional | Stryker Corporation (Tornier, Inc.) | 12/06/2024SE |
| K241609 | Tornier Humeral Reconstruction System (Tornier HRS)KWS · Traditional | Stryker Corporation (Tornier, Inc.) | 09/10/2024SE |
| K230513 | Arthrex Univers Apex OptiFit Humeral StemKWS · Traditional | Arthrex, Inc. | 09/26/2023SE |
| K222592 | AltiVate® Anatomic Shoulder AG e+ with MarkersKWS · Abbreviated | Encore Medical L.P. | 06/23/2023SE |
| K230572 | AETOS Shoulder SystemKWS · Traditional | Smith & Nephew, Inc. | 06/07/2023SE |
| K220847 | AETOS Shoulder SystemKWS · Traditional | Smith & Nephew, Inc. | 01/03/2023SE |
| K222317 | Catalyst EA Convertible Stemmed ShoulderKWS · Traditional | Catalyst Orthoscience, Inc. | 11/10/2022SE |
| K213387 | AltiVate® Anatomic Shoulder AG e+ with MarkersKWS · Traditional | Encore Medical L.P. | 07/07/2022SE |
| K213785 | SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidKWS · Special | Limacorporate | 05/13/2022SE |
| K213827 | TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…KWS · Traditional | Smith & Nephew, Inc. | 03/11/2022SE |
| K212356 | Exactech® Equinoxe® Laser Cage GlenoidKWS · Traditional | Exactech, Inc. | 03/04/2022SE |
| K212435 | Comprehensive Humeral Fracture Positioning SleevesKWS · Traditional | Biomet, Inc. | 12/10/2021SE |
| K210861 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…KWS · Traditional | Stryker GmbH | 09/03/2021SE |
| K210050 | Augmented VaultLock GlenoidKWS · Traditional | Arthrex, Inc. | 06/07/2021SE |
| K203315 | BLUEPRINT Patient Specific InstrumentationKWS · Traditional | Tornier S.A.S. | 04/15/2021SE |
| K203230 | Global Shoulder and Delta CTA systemsKWS · Traditional | Depuy Lnc. | 04/02/2021SE |
| K203026 | AltiVate® Anatomic Pegged Glenoid with MarkersKWS · Traditional | Encore Medical L.P. | 12/23/2020SE |
| K202289 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…KWS · Traditional | Stryker GmbH | 12/16/2020SE |
| K193180 | Alliance Augmented GlenoidKWS · Traditional | Zimmer, Inc. | 02/24/2020SE |
| K191247 | SmartSPACE Shoulder SystemKWS · Traditional | Techmah Medical, LLC | 11/15/2019SE |
| K191814 | Alliance GlenoidKWS · Traditional | Zimmer, Inc. | 10/23/2019SE |
| K190286 | Materialise Glenoid Positioning SystemKWS · Traditional | Materialise NV | 07/08/2019SE |
| K191318 | AEQUALIS FLEX REVIVE Shoulder SystemKWS · Special | Tornier, Inc. | 06/14/2019SE |
| K190521 | Aequalis Ascend Flex Shoulder SystemKWS · Special | Tornier S.A.S. | 06/12/2019SE |
| K190290 | AltiVate Reverse Humeral Stem, 48mmKWS · Special | Encore Medical L.P. | 04/26/2019SE |
| K182799 | Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsKWS · Traditional | Arthrex, Inc. | 03/08/2019SE |
| K183039 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…KWS · Traditional | Stryker GmbH | 02/15/2019SE |
| K183042 | SMR Lateralized Connectors with screwsKWS · Traditional | Lima Corporate S.P.A. | 01/25/2019SE |
| K181555 | Arthrex Fracture Adapter Hemi Shoulder ProsthesisKWS · Traditional | Arthrex, Inc. | 12/21/2018SE |
| K181742 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…KWS · Traditional | Stryker GmbH | 09/27/2018SE |
| K181420 | Aequalis Flex Revive Shoulder SystemKWS · Traditional | Tornier, Inc. | 09/20/2018SE |
| K171841 | Arthrex Shoulder SystemKWS · Traditional | Arthrex, Inc. | 03/29/2018SE |
| K172054 | Materialise Glenoid Positioning SystemKWS · Traditional | Materialise NV | 11/03/2017SE |
| K172351 | AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…KWS · Traditional | Encore Medical L.P. | 10/30/2017SE |
| K172210 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…KWS · Traditional | Stryker Trauma AG | 10/02/2017SE |
| K170910 | Medacta Anatomic Shoulder ProsthesisKWS · Traditional | Medacta International S.A. | 08/16/2017SE |
| K170893 | Materialise Glenoid Positioning SystemKWS · Traditional | Materialise NV | 06/19/2017SE |
| K162800 | BLUEPRINT Patient Specific InstrumentationKWS · Traditional | Tornier S.A.S. | 02/22/2017SE |
| K162697 | Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…KWS · Traditional | Custom Orthopaedic Solutions, Inc. | 02/10/2017SE |
| K161789 | BLUEPRINT Patient Specific InstrumentationKWS · Traditional | Tornier S.A.S. | 12/27/2016SE |
| K161863 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…KWS · Traditional | Stryker GmbH | 11/23/2016SE |
| K162024 | AltiVate Anatomic Shoulder SystemKWS · Traditional | Encore Medical L.P. | 11/21/2016SE |
| K161108 | Arthrex VaultLock GlenoidKWS · Special | Arthrex, Inc. | 08/29/2016SE |
| K160975 | Aequalis PerFORM+ Shoulder SystemKWS · Special | Tornier, Inc. | 06/10/2016SE |
| K160555 | BLUEPRINT Patient Specific InstrumentationKWS · Special | Tornier S.A.S. | 06/10/2016SE |
| K153602 | Materialise Glenoid Positioning SystemKWS · Traditional | Materialise NV | 04/26/2016SE |
| K153722 | SMR 3-Pegs GlenoidsKWS · Traditional | Lima Corporate S.P.A. | 04/06/2016SE |
| K160085 | Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…KWS · Special | Zimmer GmbH | 03/08/2016SE |
| K153215 | SmartBase for Arthrex Glenoid IRISKWS · Traditional | Custom Orthopaedic Solutions, Inc. | 02/19/2016SE |
| K152047 | INTEGRA TITAN Modular Total Shoulder System Fin-Lock GlenoidKWS · Traditional | Ascension Orthopedics | 12/23/2015SE |
| K152267 | Remedy® Shoulder SpacerKWS · Traditional | Osteoremedies, LLC | 12/15/2015SE |
| K153115 | Arthrex Univers Apex, Size 5 StemKWS · Special | Arthrex, Inc. | 11/23/2015SE |
| K151500 | Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)KWS · Traditional | Custom Orthopaedic Solutions | 10/05/2015SE |
| K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisKWS · Special | Tornier S.A.S. | 09/24/2015SE |
| K143256 | SMR Modular GlenoidKWS · Special | Lima Corporate S.P.A. | 05/28/2015SE |
| K150583 | Aequalis PerFORM+ Shoulder SystemKWS · Special | Tornier, Inc. | 04/23/2015SE |
| K143374 | BLUEPRINT Patient Specific InstrumentationKWS · Traditional | Tornier S.A.S. | 04/08/2015SE |
| K142403 | Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…KWS · Traditional | Zimmer GmbH | 11/24/2014SE |
| K142072 | Glenoid Intelligent Reusable Instrument System (Glenoid Iris)KWS · Traditional | Custom Orthopaedic Solutions, Inc. | 11/24/2014SE |
| K142413 | TITAN Modular Total Shoulder SystemKWS · Traditional | Ascension Orthopedics | 11/14/2014SE |
| K133349 | SMR TT Metal Back GlenoidKWS · Traditional | Lima Corporate S.P.A. | 06/03/2014SE |
| K133834 | Depuy Global Unite Shoulder SystemKWS · Traditional | Depuy(Ireland) | 04/03/2014SE |
| K140063 | Equinoxe Extra Short Humeral HeadKWS · Special | Exactech, Inc. | 02/11/2014SE |
| K133462 | Duocentric Reversed Shoulder ProsthesisKWS · Traditional | Aston Medical | 02/07/2014SE |
| K130048 | Reverse Shoulder Prosthesis MonoblockKWS · Traditional | Encore Medical L.P. | 10/29/2013SE |
| K131633 | Arthrex Univers ApexKWS · Traditional | Arthrex, Inc. | 09/27/2013SE |
| K131559 | Match Point System(Tm), Surgicase Connect, Match Point System(Tm) GuidesKWS · Traditional | Materialise NV | 09/27/2013SE |
| K131277 | Seviin Fracture ShoulderKWS · Traditional | Ingen Orthopedics, LLC | 08/28/2013SE |
| K131129 | Cas Psi ShoulderKWS · Traditional | Zimmer Cas | 08/20/2013SE |
| K130050 | Titan Reverse Shoulder SystemKWS · Traditional | Ascension Orthopedic | 06/18/2013SE |
| K130642 | SMR 3-PEGS GlenoidsKWS · Traditional | Lima Corporate S.P.A. | 06/12/2013SE |
| K131112 | Limacorporate SMR Cta Humeral HeadsKWS · Special | Lima Corporate S.P.A. | 06/07/2013SE |
| K130129 | Univers Revers Shoulder Prosthesis SystemKWS · Traditional | Arthrex, Inc. | 05/31/2013SE |
| K123122 | Glenoid Intelligent Reusable Instrument System (Glenoid Iris)KWS · Traditional | Cleveland Clinic | 04/05/2013SE |
| K123982 | Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+KWS · Special | Encore Medical L.P. | 01/23/2013SE |
| K122698 | Aequalis Ascend Flex Shoulder SystemKWS · Traditional | Tornier S.A.S. | 01/08/2013SE |
| K121220 | Equinoxe Glenoid, Uhmwpe 16 Ps=Osterior Augment Pegged, Small, Left/RightKWS · Special | Exactech, Inc. | 11/20/2012SE |
| K121493 | Ascend Shoulder SystemKWS · Special | Tornier, Inc. | 06/20/2012SE |
| K120794 | Ascend Shoulder SystemKWS · Special | Tornier, Inc. | 04/13/2012SE |
| K112438 | Titan Modular Total Shoulder SystemKWS · Special | Ascension Orthopedic | 04/11/2012SE |
| K113413 | Ascend Shoulder SystemKWS · Special | Tornier, Inc. | 03/09/2012SE |
| K120044 | Arthrex Universii XL Glenoid-Pegged, Arthrex Univers II XL Glenoid-KeeledKWS · Special | Arthrex, Inc. | 03/08/2012SE |
| K113012 | Promos Modular Shoulder SystemKWS · Traditional | Smith & Nephew, Inc. | 01/05/2012SE |
| K113309 | Exactech Equinoxe Cage GlenoidsKWS · Special | Exactech, Inc. | 12/08/2011SE |
| K111902 | Aequalis Shoulder SystemKWS · Traditional | Tornier | 11/03/2011SE |
| K111212 | SMR Shoulder System- Revision StemsKWS · Traditional | Lima Corporate S.P.A. | 07/28/2011SE |
| K110847 | SMR Shoulder System - Cta Humeral HeadsKWS · Traditional | Lima Corporate S.P.A. | 07/15/2011SE |
| K111596 | Total Shoulder SystemKWS · Special | Shoulder Innovations, LLC | 07/05/2011SE |
| K111379 | Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…KWS · Special | Exactech, Inc. | 06/08/2011SE |
| K110905 | Total Shoulder SystemKWS · Special | Shoulder Innovations, LLC | 05/24/2011SE |
| K103835 | Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (Yy=P,C…KWS · Traditional | Howmedica Osteonics Corp. | 05/05/2011SE |
| K110865 | Aequalis Ascend Modular Anatomic Shoulder SystemKWS · Special | Tornier, Inc. | 04/27/2011SE |
| K102924 | Aequalis Ascend Modular Anatomic Shoulder SystemKWS · Traditional | Tornier, Inc. | 01/31/2011SE |
| K102670 | Total Shoulder SystemKWS · Traditional | Shoulder Innovations, LLC | 01/24/2011SE |
| K103466 | Arthrex Univers II Shoulder ProsthesisKWS · Special | Arthrex, Inc. | 12/22/2010SE |
| K103419 | Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMKWS · Special | Exactech, Inc. | 12/13/2010SE |
| K093599 | Arrow Anatomical Shoulder SystemKWS · Traditional | Fournitures Hospitalieres Industrie | 11/24/2010SE |
| K103104 | Special Orthopaedic Solutions Glenoid Shoulder ComponentKWS · Special | Howmedica Osteonics Corp. | 11/22/2010SE |
| K103007 | Affiniti Total and Hemi-Shoulder SystemKWS · Special | Tornier, Inc. | 11/09/2010SE |
| K093430 | Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…KWS · Traditional | Exactech, Inc. | 09/02/2010SE |
| K100448 | Ascension Modular Total Shoulder SystemKWS · Traditional | Ascension Orthopedics, Inc. | 08/30/2010SE |
| K091196 | GRS Glenoid Resurfacing SystemKWS · Traditional | Arthrosurface, Inc. | 10/27/2009SE |
| K092122 | Global Shoulder Steptech Anchor Peg GlenoidKWS · Special | DePuy Orthopaedics, Inc. | 07/27/2009SE |
| K091751 | Depuy Delta Xtend Reverse Shoulder XLK CupKWS · Special | DePuy Orthopaedics, Inc. | 07/14/2009SE |
| K083435 | Arthrex Univers II Shoulder Pegged GlenoidKWS · Special | Arthrex, Inc. | 06/26/2009SE |
| K082120 | Aequalis Reversed Fracture Shoulder ProthesisKWS · Traditional | Tornier | 10/24/2008SE |
| K081707 | Aequalis Shoulder Fracture and Shoulder SystemsKWS · Special | Tornier, Inc. | 07/17/2008SE |
| K081620 | Modification to Depuy Delta Xtend Reverse Shoulder SystemKWS · Special | DePuy Orthopaedics, Inc. | 06/30/2008SE |
| K080402 | Encore Shoulder Primary Humeral Stem, Model 500-00, Encore Shoulder Humeral Head, Model…KWS · Traditional | Encore Medical L.P. | 03/28/2008SE |
| K071032 | Arthrex Univers II Shoulder ProsthesisKWS · Special | Arthrex, Inc. | 08/20/2007SE |
| K071090 | Trabecular Metal Glenoid- B/F Complete Shoulder SolutionKWS · Traditional | Zimmer Trabecular Metal Technology | 06/29/2007SE |
| K060694 | Modular Hybrid GlenoidKWS · Traditional | Biomet Manufacturing Corp | 12/11/2006SE |
| K060988 | Total and Hemi Shoulder SystemKWS · Traditional | Dvo Extremity Solutions, LLC | 12/06/2006SE |
| K062029 | Anatomical Shoulder Fracture SystemKWS · Traditional | Zimmer GmbH | 10/31/2006SE |
| K062113 | Solar Reunion Fracture StemKWS · Traditional | Howmedica Osteonics Corp. | 10/03/2006SE |
| K060874 | Depuy Global Ap Shoulder SystemKWS · Traditional | DePuy Orthopaedics, Inc. | 06/28/2006SE |
| K060209 | Aequalis Shoulder Fracture System & Aequalis Shoulder SystemKWS · Special | Tornier | 03/02/2006SE |
| K052472 | Depuy Global Shoulder Crosslink GlenoidKWS · Special | DePuy Orthopaedics, Inc. | 10/06/2005SE |
| K051623 | Anatomical Shoulder Keeled GlenoidKWS · Special | Zimmer GmbH | 07/19/2005SE |
| K043346 | Genesis Total Shoulder Replacement, Model 100-01-00KWS · Traditional | Genesis Medical LLC | 01/31/2005SE |
| K043077 | Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder SystemKWS · Traditional | Tornier | 12/17/2004SE |
| K043061 | The Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution, Model…KWS · Special | Zimmer Trabecular | 11/23/2004SE |
| K042021 | Exactech Equinoxe Shoulder SystemKWS · Traditional | Exactech, Inc. | 10/26/2004SE |
| K041339 | Aequalis Shoulder SystemKWS · Special | Tornier | 06/17/2004SE |
| K040610 | Versa-Dial Humeral HeadKWS · Traditional | Biomet Manufacturing, Inc. | 06/04/2004SE |
| K033506 | Comprehensive Humeral Fracture Positioning SleeveKWS · Traditional | Biomet, Inc. | 02/02/2004SE |
| K032679 | Aequalis Shoulder Fracture SystemKWS · Special | Tornier | 12/15/2003SE |
| K031449 | Modification to the Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder…KWS · Traditional | Implex Corp. | 09/23/2003SE |
| K030259 | Amatomical Shoulder with Removable HeadKWS · Traditional | Centerplus Orthopedics, Inc. | 04/24/2003SE |
| K030344 | Modular Neer 3 Humeral Stems and Modular Neer 3 Humeral HeadsKWS · Special | Smith & Nephew, Inc. | 03/04/2003SE |
| K020345 | Arthrex Univers Fracture ProsthesisKWS · Traditional | Arthrex, Inc. | 09/06/2002SE |
| K012788 | Vaporized Hydrogen Peroxide (VHP) Sterilization of Unmwpe Components in the Cofield…KWS · Traditional | Smith & Nephew, Inc. | 03/15/2002SE |
| K012378 | 3D Humeral HeadsKWS · Traditional | Smith & Nephew, Inc. | 12/13/2001SE |
| K003324 | Plasma Sprayed ShoulderKWS · Traditional | Encore Orthopedics, Inc. | 12/06/2001SE |
| K012212 | Modification to Aequalis Shoulder SystemKWS · Special | Tornier | 08/15/2001SE |
| K010124 | Arthrex Univers 30 Shoulder ProsthesisKWS · Traditional | Arthrex, Inc. | 04/06/2001SE |
| K003801 | Anatomical Press-Fit Humeral StemKWS · Traditional | Sulzer Orthopedics, Inc. | 02/28/2001SE |
| K003566 | Cofield Eccentric and Lateral Offset Humeral HeadsKWS · Traditional | Smith & Nephew, Inc. | 02/14/2001SE |
| K003832 | Sulzer Orthopedics Anatomical Shoulder Cemented Humeral StemKWS · Special | Sulzer Orthopedics, Inc. | 01/04/2001SE |
| K003728 | Modification to Aequalis Shoulder Fracture SystemKWS · Special | Tornier | 12/20/2000SE |
| K002683 | WMT Ultra-Fit Modular Shoulder SystemKWS · Traditional | Wrightmedicaltechnologyinc | 11/22/2000SE |
| K001706 | WMT Modular Shoulder SystemKWS · Traditional | Wrightmedicaltechnologyinc | 08/16/2000SE |
| K994393 | Aequalis Universal Shoulder GlenoidKWS · Traditional | Tornier | 06/22/2000SE |
| K001046 | Biopro Glenoid Component W/ Keel & W/ PostsKWS · Traditional | Biopro, Inc. | 06/08/2000SE |
| K994350 | Neer III Total Shoulder SystemKWS · Traditional | Smith & Nephew, Inc. | 05/23/2000SE |
| K994392 | Aequalis Shoulder Fracture SystemKWS · Traditional | Tornier | 03/10/2000SE |
| K000575 | Global Advantage Extended Humeral HeadKWS · Traditional | DePuy Orthopaedics, Inc. | 03/10/2000SE |
| K992899 | Bio-Modular Shoulder Offset Humeral HeadsKWS · Traditional | Biomet, Inc. | 10/21/1999SE |
| K992119 | Bio-Modular Shoulder SystemKWS · Traditional | Biomet, Inc. | 09/13/1999SE |
| K980244 | Aequalis Shoulder ProsthesisKWS · Traditional | Tornier | 08/23/1999SE |
| K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric HeadKWS · Special | DePuy Orthopaedics, Inc. | 07/12/1999SE |
| K990598 | Osteonics Solar Shoulder Humeral Bearing HeadKWS · Special | Howmedica Osteonics Corp. | 03/15/1999SE |
| K990136 | Anatomica Glenoid ComponentKWS · Traditional | Sulzer Orthopedics, Inc. | 03/01/1999SE |
| K990137 | Anatomica Humeral Stem/Head ComponentsKWS · Traditional | Sulzer Orthopedics, Inc. | 02/18/1999SE |
| K981487 | Depuy Global Shoulder GlenoidKWS · Traditional | DePuy Orthopaedics, Inc. | 07/13/1998SE |
| K974044 | Global Total Shoulder Eccentric Humeral HeadKWS · Traditional | DePuy Orthopaedics, Inc. | 01/22/1998SE |
| K971715 | Select Shoulder Offset Humeral Head ComponentsKWS · Traditional | Sulzer Orthopedics, Inc. | 08/07/1997SE |
| K962224 | Select Shoulder Concentric Humeral Head ComponentsKWS · Traditional | Intermedics Orthopedics | 08/28/1996SE |
| K962082 | Osteonics All Polyethylene Glenoid Shoulder ComponentKWS · Traditional | Osteonics Corp. | 08/13/1996SE |
| K960906 | Foundation Glenoid ComponentKWS · Traditional | Encore Orthopedics, Inc. | 04/15/1996SE |
| K955944 | Osteonics N2/VAC Packaging ProcessKWS · Traditional | Osteonics Corp. | 04/09/1996SE |
| K955767 | Cofied Modular Shoulder SystemKWS · Traditional | Smith & Nephew Richards, Inc. | 04/08/1996SN |
| K955731 | Osteonics Shoulder Humeral ComponentsKWS · Traditional | Osteonics Corp. | 03/05/1996SN |
| K952928 | Aequalis Shoulder System for Total & Hemishoulder ApplicationsKWS · Traditional | Tornier | 09/27/1995SE |
| K950521 | Osteonics All Polyethylene Glenoid Shoulder ComponentKWS · Traditional | Osteonics Corp. | 06/16/1995SE |
| K950651 | Total Shoulder ProsthesisKWS · Traditional | Encore Orthopedics, Inc. | 05/30/1995SN |
| K935802 | Select(R) Shoulder All Poly GlenoidKWS · Traditional | Intermedics Orthopedics | 05/22/1995SE |
| K943300 | Depuy Porous Coated Global ShoulderKWS · Traditional | Depuy, Inc. | 10/31/1994SN |
| K920362 | 3M Modular Shoulder SystemKWS · Traditional | 3M Health Care, Ltd. | 07/22/1993SE |
| K904880 | Buechel-Pappas Humeral Stem ComponentKWS · Traditional | Endotec, Inc. | 01/28/1991SE |
| K904879 | Beuchel-Pappas Glenoid ComponentKWS · Traditional | Endotec, Inc. | 01/28/1991SE |
| K903886 | Osteonics SR Glenoid ComponentsKWS · Traditional | Osteonics Reconstructive Products Div. | 11/20/1990SN |
| K902855 | New Jersey Total Shoulder Glenoid ComponentKWS · Traditional | Depuy, Inc. | 09/20/1990SE |
| K901434 | PapillotomeKWS · Traditional | Telemed Systems, Inc. | 06/08/1990SE |
| K895226 | Neer II Total Shoulder System & ProsthesisKWS · Traditional | 3M Company | 11/03/1989SE |
| K884943 | Intermedics Select Shoulder Metal-Backed GlenoidKWS · Traditional | Intermedics Orthopedics | 04/27/1989SN |
| K883816 | Shoulder Microstructured Humeral ProsthesisKWS · Traditional | Osteonics Corp. | 11/10/1988SE |
| K881750 | Normal Humeral ProsthesisKWS · Traditional | Osteonics Corp. | 08/30/1988SE |
| K881836 | Intermedics Select Shoulder All Plastic Glen. CompKWS · Traditional | Intermedics Orthopedics | 08/29/1988SE |
| K870262 | Fenlin II Shoulder ProsthesisKWS · Traditional | Zimmer, Inc. | 04/03/1987SE |
| K862535 | Osteonics Shoulder ProsthesisKWS · Traditional | Osteonics Corp. | 09/02/1986SE |
| K855183 | Cofield Shoulder SystemKWS · Traditional | Richards Medical Co., Inc. | 03/26/1986SE |
| K852365 | Link Shoulder Prosthesis Endo-Model SystemKWS · Traditional | Link America, Inc. | 12/16/1985SE |
| K843624 | Cofield Shoulder SystemKWS · Traditional | Richards Medical Co., Inc. | 01/10/1985SE |
| K833410 | Monospherical Glenoid Prosth. KeelKWS · Traditional | Howmedica Corp. | 11/07/1983SE |
| K801970 | Ucla ShoulderKWS · Traditional | Howmedica Corp. | 12/31/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3200-2026 | DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | Howmedica Osteonics Corp. | 07/30/2026Open, Classified |
| Z-1769-2026 Class II | Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No.…Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the… | Tornier, Inc | 03/05/2026Open, Classified |
| Z-1458-2026 Class II | Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT…Knee and Humeral socket implants contain incorrect labeling. | Encore Medical, LP | 01/15/2026Open, Classified |
| Z-1237-2026 Class II | TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are… | Tornier, Inc | 12/19/2025Open, Classified |
| Z-2548-2025 Class II | Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE…Their is a potential that the reamer may kick or bind up during or immediately prior to use. | Encore Medical, LP | 07/18/2025Open, Classified |
| Z-2547-2025 Class II | Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL…Their is a potential that the reamer may kick or bind up during or immediately prior to use. | Encore Medical, LP | 07/18/2025Open, Classified |
| Z-2546-2025 Class II | Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD…Their is a potential that the reamer may kick or bind up during or immediately prior to use. | Encore Medical, LP | 07/18/2025Open, Classified |
| Z-1415-2024 Class II | Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38…The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the… | Exactech, Inc. | 03/06/2024Open, Classified |
| Z-1414-2024 Class II | Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41…The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the… | Exactech, Inc. | 03/06/2024Open, Classified |
| Z-1413-2024 Class II | Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53…The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the… | Exactech, Inc. | 03/06/2024Open, Classified |
| Z-1412-2024 Class II | Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44…The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the… | Exactech, Inc. | 03/06/2024Open, Classified |
| Z-1411-2024 Class II | Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY…The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the… | Exactech, Inc. | 03/06/2024Open, Classified |
| Z-1410-2024 Class II | Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY…The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the… | Exactech, Inc. | 03/06/2024Open, Classified |
| Z-1409-2024 Class II | Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY…The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the… | Exactech, Inc. | 03/06/2024Open, Classified |
| Z-1408-2024 Class II | Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY…The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the… | Exactech, Inc. | 03/06/2024Open, Classified |
| Z-1407-2024 Class II | Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a)…The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the… | Exactech, Inc. | 03/06/2024Open, Classified |
| Z-1406-2024 Class II | Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a)…The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the… | Exactech, Inc. | 03/06/2024Open, Classified |
| Z-1405-2024 Class II | Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a)…The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the… | Exactech, Inc. | 03/06/2024Open, Classified |
| Z-1404-2024 Class II | Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature…The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the… | Exactech, Inc. | 03/06/2024Open, Classified |
| Z-1403-2024 Class II | Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature…The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the… | Exactech, Inc. | 03/06/2024Open, Classified |
| Z-1402-2024 Class II | Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature…The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the… | Exactech, Inc. | 03/06/2024Open, Classified |
| Z-0580-2024 Class II | Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c)…Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | Exactech, Inc. | 11/21/2023Open, Classified |
| Z-0281-2024 Class II | RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432…Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons… | Encore Medical, LP | 09/25/2023Open, Classified |
| Z-2607-2023 Class II | DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108Orthopedic device components were not subjected to final sterilization before shipment, which if implanted… | Encore Medical, LP | 08/04/2023Open, Classified |
| Z-2020-2023 Class II | AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex… | Tornier, Inc | 06/12/2023Open, Classified |
| Z-2019-2023 Class II | AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex… | Tornier, Inc | 06/12/2023Open, Classified |
| Z-2331-2021 Class II | AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00…Complaints have been received concerning the humeral stem failing to mate with the broach handles for a… | Encore Medical, LP | 06/28/2021Open, Classified |
| Z-2025-2021 Class II | Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only…Two lots have been swapped thus have the incorrect product in the package. The component may be of a… | Tornier, Inc | 05/28/2021Terminated |
| Z-0620-2021 Class II | Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number…Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the… | Biomet, Inc. | 11/25/2020Terminated |
| Z-0619-2021 Class II | Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398…Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the… | Biomet, Inc. | 11/25/2020Terminated |
| Z-0460-2021 Class II | Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, MediumThe product may be mislabeled. | Exactech, Inc. | 10/06/2020Terminated |
| Z-0459-2021 Class II | Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, MediumThe product may be mislabeled. | Exactech, Inc. | 10/06/2020Terminated |
| Z-0117-2021 Class II | AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number:…Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery. | Encore Medical, LP | 08/31/2020Terminated |
| Z-2886-2020 Class II | Match Point System The Match Point System is intended to by uses as a surgical…The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated… | Materialise N.V. | 07/17/2020Terminated |
| Z-1661-2020 Class II | BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | Biomet, Inc. | 02/26/2020Terminated |
| Z-1660-2020 Class II | BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | Biomet, Inc. | 02/26/2020Terminated |
| Z-1659-2020 Class II | BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | Biomet, Inc. | 02/26/2020Terminated |
| Z-1658-2020 Class II | BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | Biomet, Inc. | 02/26/2020Terminated |
| Z-1657-2020 Class II | BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | Biomet, Inc. | 02/26/2020Terminated |
| Z-0775-2020 Class II | Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through…Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition… | Medacta Usa Inc | 11/04/2019Terminated |
| Z-0520-2020 Class II | COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | Zimmer Biomet, Inc. | 08/21/2019Terminated |
| Z-0972-2019 Class II | Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter…The product was potentially being packaged without a taper adapter. | Zimmer Biomet, Inc. | 12/21/2018Terminated |
| Z-1260-2018 Class II | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540…It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic… | Encore Medical, Lp | 01/29/2018Completed |
| Z-1259-2018 Class II | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500…It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic… | Encore Medical, Lp | 01/29/2018Completed |
| Z-1258-2018 Class II | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460…It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic… | Encore Medical, Lp | 01/29/2018Completed |
| Z-1257-2018 Class II | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420…It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic… | Encore Medical, Lp | 01/29/2018Completed |
| Z-1256-2018 Class II | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380…It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic… | Encore Medical, Lp | 01/29/2018Completed |
| Z-1012-2018 Class II | The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total…The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was inverted… | DePuy Orthopaedics, Inc. | 11/28/2017Terminated |
| Z-0834-2018 Class II | DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants…The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a… | DePuy Orthopaedics, Inc. | 08/31/2017Terminated |
| Z-0415-2018 Class II | Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is…Potentially mislabeled. | Exactech, Inc. | 08/31/2017Terminated |