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Shoulder Prosthesis, Reverse Configuration
FDA product code PHX · Class 2 · Orthopedic
6,522
Registered devices
12,769
Adverse events
68
Recalls
205
510(k) clearances
Devices with this code
Ingen SEVIIN® Shoulder System — INGEN ORTHOPEDICS, L.L.C.Identity® Shoulder System — Zimmer, Inc.Signature ONE — Orthosoft IncTornier Perform Humeral System — TORNIER, INC.Tornier HRS Max — TORNIER, INC.Comprehensive® Reverse Shoulder — Biomet Orthopedics, LLCHumelock Reversed Shoulder — FX SOLUTIONSPRIMA — LIMACORPORATE SPAARROW Short Stem Humeral System — FOURNITURES HOSPITALIERES INDUSTRIEAGILON® XO trial cap inverse — implantcast GmbHTornier Perform Humeral System — TORNIER, INC.DELTA XTEND — DEPUY (IRELAND)PRIMA — LIMACORPORATE SPAArthrex® — ARTHREX, INC.AETOS Shoulder System — Smith & Nephew, Inc.DJO SURGICAL — Encore Medical, L.P.Comprehensive — Biomet Orthopedics, LLCAEQUALIS REVERSED FRACTURE — TORNIERAEQUALIS REVERSED II — TORNIERFlex Shoulder System — TORNIERArthrex® — ARTHREX, INC.COMPRESS DEVICE — Biomet Orthopedics, LLCArthrex® — ARTHREX, INC.LINK Embrace Shoulder System Line Extension — WALDEMAR LINK GmbH & Co. KG
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-30 | restor3d Inc. | Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws. |
| 2026-05-20 | Zimmer, Inc. | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
| 2026-05-20 | Zimmer, Inc. | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
| 2026-05-20 | Zimmer, Inc. | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
| 2026-05-20 | Zimmer, Inc. | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
| 2026-05-20 | Zimmer, Inc. | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
| 2026-04-30 | Medacta Usa Inc | Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the s |
| 2026-01-15 | Encore Medical, LP | Knee and Humeral socket implants contain incorrect labeling. |
| 2025-09-05 | Exactech, Inc. | Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance c |
| 2025-09-05 | Exactech, Inc. | Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance c |
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