Shoulder Prosthesis, Reverse Configuration
FDA product code PHX · Class II (moderate risk) · 21 CFR 888.3660 · Orthopedic
Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.
205510(k) clearances
0PMA approvals
68recalls
Implantimplanted device
Manufacturers
- Exactech, Inc. 21
- Tornier, Inc. 18
- Encore Medical L.P. 16
- Biomet Manufacturing Corp 15
- Medacta International S.A. 12
- Arthrex, Inc. 11
- Lima Corporate S.P.A. 11
- Zimmer, Inc. 10
- Fx Shoulder USA, Inc. 9
- Depuy Ireland UC 8
- Tornier S.A.S. 7
- DePuy Orthopaedics, Inc. 6
- FH Industrie 6
- Catalyst Orthoscience, Inc. 6
- Biomet, Inc. 4
- Shoulder Innovations, Inc. 4
- Depuy(Ireland) 4
- Fournitures Hospitalieres Industrie 4
- Integra LifeSciences Corp. 4
- Fx Solutions 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260556 | Veritas Shoulder SystemPHX · Traditional | Restor3D | 07/01/2026SE |
| K261683 | Augment Off-Axis Instrument SystemPHX · Special | Zimmer, Inc. | 06/16/2026SE |
| K260102 | Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…PHX · Traditional | Stryker Corporation (Tornier, Inc.) | 06/12/2026SE |
| K261016 | MSS - Humeral reverse liners extensionPHX · Traditional | Medacta International, SA | 06/10/2026SE |
| K253992 | Veritas Reverse Total Shoulder SystemPHX · Traditional | Restor3D | 05/07/2026SE |
| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesPHX · Traditional | Biomet Orthopedics | 04/15/2026SE |
| K260583 | Equinoxe® Shoulder SystemPHX · Traditional | Exactech, Inc. | 04/14/2026SE |
| K254128 | InSet Reverse Total Shoulder SystemPHX · Traditional | Shoulder Innovations, Inc. | 04/13/2026SE |
| K253674 | Blueprint Patient-Specific InstrumentationPHX · Traditional | Stryker Corporation (Tornier, S.A.S.) | 04/03/2026SE |
| K253624 | INHANCE Reverse Shoulder SystemPHX · Traditional | Depuy Ireland UC | 03/11/2026SE |
| K250644 | MSS - Monobloc stemPHX · Traditional | Medacta International S.A. | 02/03/2026SE |
| K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemPHX · Traditional | Lima Corporate S.P.A. | 01/22/2026SE |
| K252567 | AltiVate Reverse® ADLC GlenospherePHX · Traditional | Encore Medical L.P. | 01/15/2026SE |
| K252516 | N22 EZ GlenospherePHX · Traditional | Shoulder Innovations, Inc. | 01/15/2026SE |
| K254003 | JARVIS Metaphyseal StemPHX · Special | FH Industrie | 01/09/2026SE |
| K252788 | Tornier Perform Reversed Monopost Glenoid (Perform Mono)PHX · Traditional | Tornier, Inc. | 01/08/2026SE |
| K250338 | MSS - Humeral reverse liners extensionPHX · Traditional | Medacta International S.A. | 10/31/2025SE |
| K253345 | JARVIS Diaphyseal Stem StandardPHX · Special | FH Industrie | 10/29/2025SE |
| K252221 | Inset Reverse Total Shoulder SystemPHX · Traditional | Shoulder Innovations, Inc. | 09/26/2025SE |
| K252411 | JARVIS Glenoid Reverse Shoulder ProsthesisPHX · Special | FH Industrie | 08/28/2025SE |
| K252141 | AltiVate Reverse® GlenoidPHX · Special | Encore Medical L.P. | 08/05/2025SE |
| K243448 | Equinoxe® Shoulder SystemPHX · Traditional | Exactech, Inc. | 08/01/2025SE |
| K243826 | SMR Reverse HP Shoulder SystemPHX · Traditional | Lima Corporate S.P.A. | 07/03/2025SE |
| K243643 | restor3d Reverse Total Shoulder Arthroplasty SystemPHX · Traditional | Restor3D | 05/19/2025SE |
| K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…PHX · Special | Encore Medical L.P. | 05/16/2025SE |
| K242253 | JARVIS Glenoid Reverse Shoulder ProsthesisPHX · Traditional | FH Industrie | 11/25/2024SE |
| K241491 | Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidPHX · Traditional | Stryker Corporation (Tornier, S.A.S.) | 10/10/2024SE |
| K233482 | Equinoxe® Central Screw Baseplate SystemPHX · Traditional | Exactech, Inc. | 07/18/2024SE |
| K233481 | AltiVate Reverse® GlenoidPHX · Traditional | Encore Medical L.P. | 05/29/2024SE |
| K241043 | Augment Off-Axis Instrument SystemPHX · Special | Fix Surgical | 05/15/2024SE |
| K240278 | Full Wedge Lateralized and Augmented BaseplatesPHX · Traditional | Fx Shoulder USA, Inc. | 05/15/2024SE |
| K234105 | Catalyst F1x Shoulder SystemPHX · Traditional | Catalyst Orthoscience, Inc. | 04/05/2024SE |
| K233148 | Augment Off-Axis Instrument SystemPHX · Traditional | Fix Surgical | 03/22/2024SE |
| K232265 | BLUEPRINT Patient Specific InstrumentationPHX · Traditional | Tornier S.A.S. | 02/21/2024SE |
| K231445 | LINK Embrace Shoulder System - Reverse ConfigurationPHX · Traditional | Waldemar Link GmbH & Co. KG | 11/16/2023SE |
| K231911 | Glenoid Reconstruction System Full Wedge BaseplatePHX · Traditional | Medacta International S.A. | 11/09/2023SE |
| K232583 | Catalyst R1 Reverse Shoulder SystemPHX · Special | Catalyst Orthoscience, Inc. | 09/20/2023SE |
| K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysPHX · Traditional | Exactech, Inc. | 09/14/2023SE |
| K232226 | ARROW Off-Centred Humeral InsertPHX · Special | FH Industrie | 08/29/2023SE |
| K223801 | FX V135(TM) Shoulder ProsthesisPHX · Traditional | Fx Shoulder USA, Inc. | 06/05/2023SE |
| K223655 | Catalyst R1 Reverse Shoulder SystemPHX · Traditional | Catalyst Orthoscience, Inc. | 05/09/2023SE |
| K230366 | Arthrex Univers Revers Monoblock Stem Size 4/33PHX · Traditional | Arthrex, Inc. | 04/10/2023SE |
| K214001 | Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemPHX · Traditional | Biomet Manufacturing Corp | 03/15/2023SE |
| K223211 | INHANCETM Shoulder System Humeral Stems and StemlessPHX · Traditional | Depuy Ireland UC | 12/02/2022SE |
| K213459 | Glenoid Reconstruction SystemPHX · Traditional | Medacta International S.A. | 11/23/2022SE |
| K222936 | Humeris® 135 Shoulder SystemPHX · Traditional | Fx Shoulder USA, Inc. | 11/07/2022SE |
| K220914 | Tornier Perform Humeral System FracturePHX · Traditional | Tornier, Inc. | 10/14/2022SE |
| K221467 | INHANCETM Reverse Glenoid Peripheral PostsPHX · Traditional | Depuy Ireland UC | 08/31/2022SE |
| K213349 | Catalyst R1 Reverse Shoulder SystemPHX · Traditional | Catalyst Orthoscience, Inc. | 06/23/2022SE |
| K213117 | FX V135 Shoulder ProsthesisPHX · Traditional | Fx Shoulder USA, Inc. | 06/07/2022SE |
| K212737 | INHANCE Reverse Shoulder SystemPHX · Traditional | Depuy Ireland UC | 04/21/2022SE |
| K212800 | PRIMA Humeral System and SMR Glenosphere Ø42PHX · Traditional | Lima Corporate S.P.A. | 02/25/2022SE |
| K202024 | ARROW Short Stem Humeral SystemPHX · Traditional | FH Industrie | 11/30/2021SE |
| K212992 | LINK® Embrace Shoulder System - Reverse ConfigurationPHX · Traditional | Waldemar Link GmbH & Co. KG | 11/18/2021SE |
| K212415 | Arthrex Modular Glenoid System-Titanium GlenospherePHX · Traditional | Arthrex, Inc. | 11/17/2021SE |
| K211359 | Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient…PHX · Traditional | Tornier, Inc. | 11/12/2021SE |
| K211729 | Comprehensive® Convertible Glenoid - Vivacit-E LinerPHX · Traditional | Biomet Manufacturing Corp | 11/04/2021SE |
| K213124 | Tomier Perform Reversed Glenoid Cannulated GlenospheresPHX · Special | Tornier, Inc. | 10/26/2021SE |
| K212710 | GLOBAL UNITE Platform Shoulder SystemPHX · Special | Depuy Ireland UC | 09/15/2021SE |
| K211074 | Univers Revers Modular Glenoid System, Standard Augment BaseplatesPHX · Traditional | Arthrex, Inc. | 09/02/2021SE |
| K210790 | Lateralized and Augmented BaseplatesPHX · Traditional | Fx Shoulder USA, Inc. | 08/25/2021SE |
| K210533 | Inset Reverse Total Shoulder SystemPHX · Traditional | Shoulder Innovations, Inc. | 08/20/2021SE |
| K211553 | Tecomet Global Unite Short Stem InstrumentationPHX · Traditional | Symmetry Medical Manufacturing Inc. Dba Tecomet… | 08/04/2021SE |
| K211991 | Catalyst R1 Reverse Shoulder SystemPHX · Special | Catalyst Orthoscience, Inc. | 07/28/2021SE |
| K203694 | DELTA XTEND Reverse Shoulder SystemPHX · Traditional | Depuy Ireland UC | 07/22/2021SE |
| K210717 | Bone Screws dia. 5,0 mmPHX · Traditional | Lima Corporate S.P.A. | 07/12/2021SE |
| K203375 | OVOMotion Reverse Shoulder Arthroplasty SystemPHX · Traditional | Arthrosurface, Inc. | 06/24/2021SE |
| K210207 | Humeral Eccentric Reverse MetaphysisPHX · Traditional | Medacta International S.A. | 03/26/2021SE |
| K203755 | Shoulder System - TiNbN CoatingPHX · Traditional | Medacta International S.A. | 03/02/2021SE |
| K210167 | DELTA XTEND Reverse Shoulder SystemPHX · Special | DePuy Orthopaedics, Inc. | 02/19/2021SE |
| K202232 | Comprehensive Vault Reconstruction SystemPHX · Traditional | Biomet Manufacturing Corp | 02/19/2021SE |
| K202611 | Catalyst OrthoScience R1 Reverse Shoulder SystemPHX · Traditional | Catalyst Orthoscience, Inc. | 02/12/2021SE |
| K200368 | LINK Embrace Shoulder System - Reverse ConfigurationPHX · Traditional | Waldemar Link GmbH & Co. KG | 02/05/2021SE |
| K202098 | GLOBAL UNITE Platform Shoulder SystemPHX · Traditional | Depuy Ireland UC | 11/25/2020SE |
| K200171 | SMR TT Augmented Glenoid SystemPHX · Traditional | Lima Corporate S.P.A. | 11/19/2020SE |
| K200895 | Univers Revers Modular Glenoid System, Half Augment BaseplatePHX · Traditional | Arthrex, Inc. | 08/13/2020SE |
| K193175 | Lateralized GlenospherePHX · Traditional | Medacta Inernational SA | 08/11/2020SE |
| K191146 | Humelock TiN Coated GlenospherePHX · Traditional | Fx Shoulder USA, Inc. | 07/15/2020SE |
| K193394 | Humeral Cup Stability & Humeral Cup 135/145o StabilityPHX · Traditional | Fx Shoulder USA, Inc. | 04/29/2020SE |
| K193373 | Comprehensive® Reverse ShoulderPHX · Traditional | Biomet, Inc. | 04/15/2020SE |
| K192967 | Medacta Shoulder SystemPHX · Traditional | Medacta International S.A. | 03/25/2020SE |
| K192855 | DELTA XTEND(TM) Reverse Shoulder SystemPHX · Traditional | Depuy(Ireland) | 02/24/2020SE |
| K192799 | Glenoid Baseplate with ScrewPHX · Traditional | Fx Shoulder USA, Inc. | 02/21/2020SE |
| K193098 | Exactech® Equinoxe® Reverse Shoulder GlenospheresPHX · Special | Exactech, Inc. | 02/20/2020SE |
| K193099 | Anatomical Shoulder SystemPHX · Traditional | Zimmer GmbH | 01/29/2020SE |
| K193372 | Univers Revers Modular Glenoid System (Augemented baseplates)PHX · Special | Arthrex, Inc. | 01/10/2020SE |
| K191960 | Arthrex Univers Revers Modular Glenoid SystemPHX · Special | Arthrex, Inc. | 12/23/2019SE |
| K190738 | MyShoulder Placement GuidesPHX · Traditional | Medacta International S.A. | 12/13/2019SE |
| K190588 | Integra TITAN Reverse Shoulder SystemPHX · Traditional | Integra LifeSciences Corporation | 12/02/2019SE |
| K191746 | SMR TT Augmented Glenoid SystemPHX · Traditional | Lima Corporate S.P.A. | 11/22/2019SE |
| K192206 | 32mm Glenosphere and Humeral CupPHX · Traditional | Fx Shoulder USA, Inc. | 10/08/2019SE |
| K192448 | Delta Xtend Revers Shoulder SystemPHX · Special | Depuy(Ireland) | 10/04/2019SE |
| K191561 | Exactech Equinoxe Humeral Augmented TraysPHX · Traditional | Exactech, Inc. | 08/20/2019SE |
| K183077 | Delta Xtend Reverse Shoulder SystemPHX · Traditional | Depuy(Ireland) | 05/17/2019SE |
| K183696 | Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidPHX · Special | Tornier, Inc. | 01/30/2019SE |
| K181826 | Glenoid Polyaxial Non-locking ScrewsPHX · Traditional | Medacta International S.A. | 12/10/2018SE |
| K182536 | Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…PHX · Special | Exactech, Inc. | 10/12/2018SE |
| K181999 | Integra TITAN Reverse Shoulder SystemPHX · Traditional | Integra LifeSciences Corporation | 10/12/2018SE |
| K182039 | Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayPHX · Traditional | Arthrex, Inc. | 09/28/2018SE |
| K181611 | Comprehensive Reverse Shoulder SystemPHX · Traditional | Biomet Manufacturing Corp | 09/24/2018SE |
| K180632 | Exactech Equinoxe Small Reverse Shoulder SystemPHX · Special | Exactech, Inc. | 07/25/2018SE |
| K173717 | Integra TITAN Reverse Shoulder SystemPHX · Special | Integra LifeSciences Corporation | 06/21/2018SE |
| K173900 | Arthrex Univers Revers Modular Glenoid SystemPHX · Traditional | Arthrex, Inc. | 04/20/2018SE |
| K180089 | Medacta Shoulder System Short Humeral DiaphysisPHX · Traditional | Medacta International S.A. | 04/05/2018SE |
| K172371 | Arthrex UNIVERS REVERS COATED BASEPLATEPHX · Traditional | Arthrex, Inc. | 03/22/2018SE |
| K173411 | Comprehensive Segmental Revision System (SRS)PHX · Traditional | Biomet Manufacturing Corp | 02/08/2018SE |
| K171789 | ARROW Reverse Porous GlenoidPHX · Traditional | Fournitures Hospitalieres Industrie | 01/23/2018SE |
| K170748 | GLOBAL UNITE Platform Shoulder SystemPHX · Traditional | Depuy Ireland UC | 01/11/2018SE |
| K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…PHX · Traditional | Biomet Manufacturing Corp | 01/03/2018SE |
| K173073 | AltiVate Anatomic to Reverse Conversion ModulePHX · Traditional | Encore Medical L.P. | 12/26/2017SE |
| K170414 | Arthrex Univers Revers Apex Humeral StemsPHX · Traditional | Arthrex, Inc. | 12/14/2017SE |
| K171058 | Medacta Shoulder System: Threaded Glenoid BaseplatePHX · Traditional | Medacta International S.A. | 12/13/2017SE |
| K172767 | Zimmer Trabecular Metal Reverse Shoulder System, Mini GlenoidPHX · Traditional | Zimmer, Inc. | 11/30/2017SE |
| K170452 | Medacta Shoulder SystemPHX · Traditional | Medacta International S.A. | 10/05/2017SE |
| K170711 | ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemPHX · Traditional | Zimmer GmbH | 06/01/2017SE |
| K163669 | Humeris ShoulderPHX · Traditional | Fx Solutions | 05/17/2017SE |
| K162325 | Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…PHX · Special | Exactech, Inc. | 03/06/2017SE |
| K161120 | SMR TT Metal Back Glenoid, Bone Graft instrumentsPHX · Traditional | Lima Corporate S.P.A. | 02/21/2017SE |
| K162726 | Exactech® Equinoxe® Preserve StemPHX · Traditional | Exactech, Inc. | 02/01/2017SE |
| K162455 | Humelock Reversed ShoulderPHX · Traditional | Fx Solutions | 01/17/2017SE |
| K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidPHX · Traditional | Tornier, Inc. | 11/15/2016SE |
| K161189 | Integra TITAN Reverse Shoulder SystemPHX · Traditional | Integra LifeSciences Corporation | 08/25/2016SE |
| K152754 | Comprehensive Vault Reconstruction System (VRS)PHX · Traditional | Biomet Manufacturing Corp | 05/16/2016SE |
| K152966 | Aequalis Fx2PHX · Special | Tornier S.A.S. | 01/14/2016SE |
| K150488 | Humelock II Reversible Shoulder SystemPHX · Traditional | Fx Solutions | 11/13/2015SE |
| K150568 | ARROW Humeral stems size 6 and 16PHX · Traditional | Fournitures Hospitalieres Industrie | 10/29/2015SE |
| K150458 | Exactech Equinoxe Reverse Shoulder 46x21mm GlenospherePHX · Special | Exactech, Inc. | 05/14/2015SE |
| K142778 | ARROW Reverse Shoulder long keel and short keel glenoid basePHX · Traditional | Fournitures Hospitalieres Industrie | 03/20/2015SE |
| K142863 | Univers Rivers Shoulder Prosthesis SystemPHX · Traditional | Arthrex, Inc. | 11/25/2014SE |
| K141345 | Aequalis FX2PHX · Traditional | Tornier S.A.S. | 11/18/2014SE |
| K142139 | SMR 40MM GlenospherePHX · Traditional | Lima Corporate S.P.A. | 11/07/2014SE |
| K141990 | Encore Humeral Shoulder StemPHX · Traditional | Encore Medical L.P. | 11/07/2014SE |
| K140478 | Aequalis Reversed Shoulder ProsthesisPHX · Traditional | Tornier S.A.S. | 08/06/2014SE |
| K140082 | Aequalis(Tm) Ascent(Tm) Flex Shoulder SystemPHX · Traditional | Tornier S.A.S. | 07/18/2014SE |
| K140652 | Porous Coated Comprehensive Fracture StemsPHX · Traditional | Biomet Manufacturing Corp | 07/03/2014SE |
| K141029 | Tornier Aequalis Adjustable Reverse Shoulder SystemPHX · Special | Tornier, Inc. | 06/18/2014SE |
| K141006 | RSP Humeral Socket InsertPHX · Special | Djo Global | 06/05/2014SE |
| K133378 | Zimmer Trabecular Metal Reverse Shoulder SystemPHX · Traditional | Zimmer, Inc. | 05/12/2014SE |
| K140904 | RSP Monoblock Stem with P2 Coating, Size 6PHX · Special | Encore Medical L.P. | 05/06/2014SE |
| K130550 | RSP Modular Glenoid Baseplate, Glenoid Taper Adapter, Retaining ScrewPHX · Traditional | Encore Medical L.P. | 03/24/2014SE |
| K130895 | Reunion Rsa Shoulder SystemPHX · Traditional | Howmedica Osteonics Corp. | 12/27/2013SE |
| K132285 | Aequalis Reversed Shoulder ProsthesisPHX · Traditional | Tornier S.A.S. | 12/05/2013SE |
| K131231 | Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…PHX · Traditional | Tornier S.A.S. | 10/16/2013SE |
| K130390 | Comprehensive Convertible GlenoidPHX · Traditional | Biomet Manufacturing, Inc. | 10/09/2013SE |
| K131353 | Comprehensive Reverse Shoulder - Titanium GlenospherePHX · Traditional | Biomet Manufacturing Corp | 10/08/2013SE |
| K132239 | Comprehensive Reverse Shoulder ScrewsPHX · Traditional | Biomet Manufacturing Corp | 09/06/2013SE |
| K131575 | Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…PHX · Special | Exactech, Inc. | 07/03/2013SE |
| K130661 | Zimmer Trabecular Metal Reverse Shoulder SystemPHX · Traditional | Zimmer, Inc. | 05/09/2013SE |
| K121067 | Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlatePHX · Special | Exactech, Inc. | 12/06/2012SE |
| K122692 | Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral StemsPHX · Traditional | Zimmer, Inc. | 12/03/2012SE |
| K122442 | Depuy Cta Reverse Shoulder SystemPHX · Special | Depuy France | 09/06/2012SE |
| K121183 | Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsPHX · Traditional | Biomet Corporation | 07/26/2012SE |
| K112193 | Arrow Reverse Shoulder SystemPHX · Traditional | Fournitures Hospitalieres Industrie | 07/12/2012SE |
| K120374 | Seviin Reverse ShoulderPHX · Traditional | Ingen Orthopedics, LLC | 07/09/2012SE |
| K120739 | Aequalis Adjustable Modular Reverse Shoulder SystemPHX · Traditional | Tornier, Inc. | 07/05/2012SE |
| K120174 | Deput Delta Xtend Reverse ShoulderPHX · Traditional | Depuy France | 06/11/2012SE |
| K112144 | Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…PHX · Special | Tornier | 03/13/2012SE |
| K113254 | SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsPHX · Traditional | Lima Corporate S.P.A. | 02/24/2012SE |
| K120121 | Comprehensive Reverse Shoulder-Mini BaseplatePHX · Special | Biomet, Inc. | 02/16/2012SE |
| K113069 | Comprehensive Reverse Shoulder Humeral TrayPHX · Traditional | Biomet Manufacturing Corp | 01/11/2012SE |
| K113523 | Limacorporate SMR Reverse Shoulder SystemPHX · Special | Lima Corporate S.P.A. | 12/20/2011SE |
| K113121 | Comprehensive Reverse ShoulderPHX · Special | Biomet Manufacturing, Inc. | 12/16/2011SE |
| K112069 | RSP Glenoid Baseplate Porous CoatedPHX · Traditional | Encore Medical L.P. | 11/15/2011SE |
| K103251 | Duocentric ReversedPHX · Traditional | Aston Medical | 10/28/2011SE |
| K112615 | Aequalis Ascend Modular Reverse Shoulder SystemPHX · Special | Tornier, Inc. | 10/11/2011SE |
| K111735 | Reverse Shoulder Prosthesis Monoblock Hemi AdapterPHX · Traditional | Encore Medical L.P. | 10/03/2011SE |
| K111629 | Turon RSP Socket Shell-Neutral Model 508-02-000, Turon RSP Socket Shell-Offset Model…PHX · Traditional | Encore Medical L.P. | 09/16/2011SE |
| K110598 | SMR Reverse Shoulder SystemPHX · Traditional | Lima Corporate S.P.A. | 08/18/2011SE |
| K111061 | Reverse Shoulder Monoblock Prosthesis (RSP)PHX · Special | Encore Medical L.P. | 07/20/2011SE |
| K110599 | Aequalis Ascend Modular Reverse Shoulder SystemPHX · Traditional | Tornier, Inc. | 06/14/2011SE |
| K110708 | Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…PHX · Special | Exactech, Inc. | 04/01/2011SE |
| K103208 | Reverse Shoulder Prosthesis Monoblock StemPHX · Traditional | Encore Medical L.P. | 01/31/2011SE |
| K101996 | Depuy Global Unite Shoulder SystemPHX · Traditional | Depuy(Ireland) | 12/15/2010SE |
| K102951 | Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…PHX · Special | Exactech, Inc. | 11/04/2010SE |
| K093803 | Bio-Modular Reverse SholderPHX · Traditional | Biomet Manufacturing Corp | 10/19/2010SE |
| K101909 | Exactech Equinoxe, Platform Fracture StemPHX · Special | Exactech, Inc. | 08/02/2010SE |
| K100741 | Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts…PHX · Special | Encore Medical L.P. | 08/02/2010SE |
| K093275 | Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerPHX · Special | Exactech, Inc. | 05/27/2010SE |
| K100142 | Aequalis Reversed Shoulder ProsthesisPHX · Traditional | Tornier | 05/06/2010SE |
| K092900 | Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemPHX · Traditional | Exactech, Inc. | 01/07/2010SE |
| K092873 | Reverse Shoulder ProsthesisPHX · Special | Djo Surgical | 10/27/2009SE |
| K082702 | Exactech Equinoxe Reverse Shoulder SYSTEM+15MM Humeral Adapter TrayPHX · Special | Exactech, Inc. | 10/10/2008SE |
| K081016 | Smith & Nephew, Inc., Promos Reverse Shoulder SystemPHX · Traditional | Smith & Nephew, Inc. | 09/05/2008SE |
| K081059 | Aequalis Reversed Shoulder ProsthesisPHX · Special | Tornier | 07/17/2008SE |
| K080642 | Comprehensive Reverse ShoulderPHX · Traditional | Biomet, Inc. | 07/09/2008SE |
| K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewPHX · Special | Exactech, Inc. | 02/29/2008SE |
| K073676 | Depuy Delta Xtend Reverse Shoulder High Mobility CupPHX · Special | DePuy Orthopaedics, Inc. | 01/29/2008SE |
| K072804 | Comprehensive RS Shoulder SystemPHX · Traditional | Biomet Manufacturing Corp | 12/12/2007SE |
| K071948 | Aequalis Reversed AdapterPHX · Traditional | Tornier | 10/18/2007SE |
| K071379 | Delta Xtend Reverse Shoulder Modular StemPHX · Traditional | DePuy Orthopaedics, Inc. | 09/11/2007SE |
| K063569 | Equinoxe Reverse Shoulder SystemPHX · Traditional | Exactech, Inc. | 02/23/2007SE |
| K062250 | Delta Xtend Reverse Shoulder SystemPHX · Traditional | DePuy Orthopaedics, Inc. | 02/02/2007SE |
| K062116 | Delta Cta Reverse Shoulder System Humeral HeadsPHX · Special | DePuy Orthopaedics, Inc. | 08/18/2006SE |
| K061439 | Aequalis Reversed ProsthesisPHX · Special | Tornier | 07/20/2006SE |
| K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMPHX · Special | Zimmer, Inc. | 05/19/2006SE |
| K053274 | Anatomical Shoulder Inverse/ReversePHX · Traditional | Zimmer GmbH | 01/25/2006SE |
| K052906 | Zimmer Trabecular Metal Reverse Shoulder SystemPHX · Traditional | Zimmer, Inc. | 12/19/2005SE |
| K052086 | Encore Reverse Shoulder Prosthesis Humeral Stem AdapterPHX · Special | Encore Medical, Inc. | 08/31/2005SE |
| K051075 | Encore Reverse Shoulder ProsthesisPHX · Special | Encore Medical L.P. | 05/27/2005SE |
| K050315 | Delta Humeral CupsPHX · Special | DePuy Orthopaedics, Inc. | 05/16/2005SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2987-2026 Class II | Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard…Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the… | restor3d Inc. | 06/30/2026Open, Classified |
| Z-2531-2026 Class II | Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number:…Five complaints have been received identifying issues where the plastic guides were catching during reaming… | Zimmer, Inc. | 05/20/2026Open, Classified |
| Z-2530-2026 Class II | Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number:…Five complaints have been received identifying issues where the plastic guides were catching during reaming… | Zimmer, Inc. | 05/20/2026Open, Classified |
| Z-2529-2026 Class II | Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide…Five complaints have been received identifying issues where the plastic guides were catching during reaming… | Zimmer, Inc. | 05/20/2026Open, Classified |
| Z-2528-2026 Class II | Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide…Five complaints have been received identifying issues where the plastic guides were catching during reaming… | Zimmer, Inc. | 05/20/2026Open, Classified |
| Z-2527-2026 Class II | Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide…Five complaints have been received identifying issues where the plastic guides were catching during reaming… | Zimmer, Inc. | 05/20/2026Open, Classified |
| Z-2618-2026 Class II | Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971…Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to… | Medacta Usa Inc | 04/30/2026Open, Classified |
| Z-1460-2026 Class II | Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET…Knee and Humeral socket implants contain incorrect labeling. | Encore Medical, LP | 01/15/2026Open, Classified |
| Z-0537-2026 Class II | Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog…Due to products that have not completed design updates and performance testing being released/distributed.… | Exactech, Inc. | 09/05/2025Open, Classified |
| Z-0536-2026 Class II | Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog…Due to products that have not completed design updates and performance testing being released/distributed.… | Exactech, Inc. | 09/05/2025Open, Classified |
| Z-0535-2026 Class II | Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog…Due to products that have not completed design updates and performance testing being released/distributed.… | Exactech, Inc. | 09/05/2025Open, Classified |
| Z-2562-2025 Class II | Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER…Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification… | Exactech, Inc. | 08/15/2025Open, Classified |
| Z-2561-2025 Class II | Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM…Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification… | Exactech, Inc. | 08/15/2025Open, Classified |
| Z-2011-2025 Class II | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm…Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included… | Encore Medical, LP | 05/28/2025Open, Classified |
| Z-2010-2025 Class II | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm…Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included… | Encore Medical, LP | 05/28/2025Open, Classified |
| Z-2009-2025 Class II | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm…Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included… | Encore Medical, LP | 05/28/2025Open, Classified |
| Z-2008-2025 Class II | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm…Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included… | Encore Medical, LP | 05/28/2025Open, Classified |
| Z-2025-2025 Class II | PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, SterileThere is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the… | Limacorporate S.p.A | 05/19/2025Open, Classified |
| Z-2024-2025 Class II | PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, SterileThere is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the… | Limacorporate S.p.A | 05/19/2025Open, Classified |
| Z-1738-2025 Class II | Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for…A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions… | Tornier S.A.S. | 04/10/2025Open, Classified |
| Z-1883-2024 Class II | Stryker Blueprint Software, Catalog #BPUE001.The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and… | Tornier S.A.S. | 04/16/2024Open, Classified |
| Z-1425-2024 Class II | Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number…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-1424-2024 Class II | Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00…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-1423-2024 Class II | Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number…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-1422-2024 Class II | Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00…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-1421-2024 Class II | Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13…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-1420-2024 Class II | Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder…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-1419-2024 Class II | Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number…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-1418-2024 Class II | Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00…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-1417-2024 Class II | Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number…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-1416-2024 Class II | Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00…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-0773-2024 Class II | Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L:…The incorrect device is contained in the labeled package. | Tornier, Inc | 01/03/2024Open, Classified |
| Z-0626-2024 Class II | REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2Mislabeling | Encore Medical, LP | 10/05/2023Completed |
| Z-0625-2024 Class II | Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm…Mislabeling | Encore Medical, LP | 10/05/2023Completed |
| Z-0282-2024 Class II | RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic…Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons… | Encore Medical, LP | 09/25/2023Open, Classified |
| Z-0113-2024 Class II | stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset…One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm… | Tornier, Inc | 09/15/2023Open, Classified |
| Z-0532-2024 Class II | RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver | Encore Medical, LP | 09/06/2023Open, Classified |
| Z-0098-2024 Class II | REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF:…Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30… | Encore Medical, LP | 08/22/2023Open, Classified |
| Z-0843-2024 Class II | Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210Centered glenosphere box may contain an eccentric glenosphere. | FX Shoulder | 08/08/2023Open, Classified |
| Z-2606-2023 Class II | DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF:…Orthopedic device components were not subjected to final sterilization before shipment, which if implanted… | Encore Medical, LP | 08/04/2023Open, Classified |
| Z-0490-2022 Class II | GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may… | DePuy Orthopaedics, Inc. | 12/07/2021Terminated |
| Z-0489-2022 Class II | GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may… | DePuy Orthopaedics, Inc. | 12/07/2021Terminated |
| Z-0488-2022 Class II | GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may… | DePuy Orthopaedics, Inc. | 12/07/2021Terminated |
| Z-0487-2022 Class II | GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may… | DePuy Orthopaedics, Inc. | 12/07/2021Terminated |
| Z-0486-2022 Class II | GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may… | DePuy Orthopaedics, Inc. | 12/07/2021Terminated |
| Z-0485-2022 Class II | GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may… | DePuy Orthopaedics, Inc. | 12/07/2021Terminated |
| Z-0484-2022 Class II | GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may… | DePuy Orthopaedics, Inc. | 12/07/2021Terminated |
| Z-0483-2022 Class II | GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may… | DePuy Orthopaedics, Inc. | 12/07/2021Terminated |
| Z-1977-2021 Class II | Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray…The HAT trial contains a retaining ring that has shown the potential to disengage during use. | Exactech, Inc. | 05/11/2021Completed |
| Z-1131-2021 Class II | Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for…Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder… | Biomet, Inc. | 01/15/2021Terminated |