Home › Device types › KWS
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
FDA product code KWS · Class 2 · Orthopedic
10,911
Registered devices
23,762
Adverse events
153
Recalls
191
510(k) clearances
Devices with this code
Equinoxe — Exactech, Inc.PROMOS — Smith & Nephew, Inc.Comprehensive® Shoulder Instruments — Biomet Orthopedics, LLCArthrex® — ARTHREX, INC.Anatomical Shoulder™ — Zimmer GmbHAlliance® — Zimmer, Inc.DELTA XTEND — DEPUY (IRELAND)Comprehensive® Shoulder System — Biomet Orthopedics, LLCAEQUALIS — TORNIERSMR TT Hybrid Glenoid — LIMACORPORATE SPAEquinoxe — Exactech, Inc.SmartBone — CUSTOM ORTHOPAEDIC SOLUTIONS, INC.AEQUALIS REVERSED — TORNIERAequalis™ Ascend™ Flex — TORNIEREquinoxe — Exactech, Inc.SHOULDER INNOVATIONS TSA SYSTEM — Shoulder Innovations, Inc.Tornier Flex Shoulder System — TORNIERShoulder Innovations InSet 185 Instrument Case/Tray — Shoulder Innovations, Inc.Aequalis™ Adjustable Reversed — TORNIER, INC.trial cementless glenoid 44 — FOURNITURES HOSPITALIERES INDUSTRIEIdentity™ — Zimmer, Inc.DJO SURGICAL — Encore Medical, L.P.REUNION — Stryker GmbHTornier Perform Humeral System — TORNIER, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-30 | Howmedica Osteonics Corp. | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential f |
| 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 |
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