Home › Device types › KWS
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
FDA product code KWS · Class 2 · Orthopedic
10,788
Registered devices
23,247
Adverse events
152
Recalls
191
510(k) clearances
Devices with this code
SHOULDER INNOVATIONS TSA SYSTEM — Shoulder Innovations, Inc.GLOBAL UNITE — DEPUY (IRELAND)Equinoxe — Exactech, Inc.Equinoxe — Exactech, Inc.Signature ONE — Orthosoft IncTornier Perform Humeral System — TORNIER, INC.Tornier HRS Max — TORNIER, INC.Comprehensive® Reverse Shoulder — Biomet Orthopedics, LLCSMR Shoulder — LIMACORPORATE SPAPRIMA — LIMACORPORATE SPAAequalis™ Adjustable Reversed — TORNIER, INC.ARROW Short Stem Humeral System — FOURNITURES HOSPITALIERES INDUSTRIETornier Perform Humeral System — TORNIER, INC.DELTA XTEND — DEPUY (IRELAND)DJO SURGICAL — Encore Medical, L.P.SOLAR — Howmedica Osteonics Corp.PRIMA — LIMACORPORATE SPAAETOS Shoulder System — Smith & Nephew, Inc.Anatomical Shoulder# — Zimmer GmbHComprehensive — Biomet Orthopedics, LLCAequalis™ Ascend™ Flex — TORNIERPERFORM™ HUMERAL SYSTEM — TORNIER, INC.AEQUALIS REVERSED FRACTURE — TORNIERAEQUALIS™ PerFORM — TORNIER
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-05 | Tornier, Inc | Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with t |
| 2026-01-15 | Encore Medical, LP | Knee and Humeral socket implants contain incorrect labeling. |
| 2025-12-19 | Tornier, Inc | A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the |
| 2025-07-18 | Encore Medical, LP | Their is a potential that the reamer may kick or bind up during or immediately prior to use. |
| 2025-07-18 | Encore Medical, LP | Their is a potential that the reamer may kick or bind up during or immediately prior to use. |
| 2025-07-18 | Encore Medical, LP | Their is a potential that the reamer may kick or bind up during or immediately prior to use. |
| 2024-03-06 | Exactech, Inc. | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack |
| 2024-03-06 | Exactech, Inc. | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack |
| 2024-03-06 | Exactech, Inc. | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack |
| 2024-03-06 | Exactech, Inc. | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack |
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