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Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
FDA product code PKC · Class 2 · Orthopedic
548
Registered devices
363
Adverse events
3
Recalls
20
510(k) clearances
Devices with this code
Shoulder Innovations Humeral Stemless System — Shoulder Innovations, Inc.Simpliciti™ — TORNIER, INC.Comprehensive® Shoulder System — Biomet Orthopedics, LLCEquinoxe — Exactech, Inc.GLOBAL ICON — DEPUY (IRELAND)FX V135 — FX SOLUTIONSGLOBAL ICON — DEPUY (IRELAND)SMR STEMLESS — LIMACORPORATE SPASMR STEMLESS — LIMACORPORATE SPACOMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, LLCOsseoFit™ Stemless Shoulder — Zimmer, Inc.Simpliciti™ — TORNIER, INC.DJO SURGICAL — Encore Medical, L.P.Comprehensive® Shoulder System — Biomet Orthopedics, LLCGLOBAL ICON — DEPUY (IRELAND)OsseoFit™ Stemless Shoulder — Zimmer, Inc.Equinoxe — Exactech, Inc.DJO SURGICAL — Encore Medical, L.P.GLOBAL ICON — DEPUY (IRELAND)Tornier Simpliciti® Shoulder System — TORNIER, INC.COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, LLCINHANCE — DEPUY (IRELAND)FX V135 — FX Shoulder Solutions, Inc.Easytech Anatomical Shoulder System — FX SOLUTIONS
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-29 | Tornier, Inc | One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device). |
| 2019-10-10 | Zimmer Biomet, Inc. | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| 2019-08-21 | Zimmer GmbH | Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14. |
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