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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
491
Registered devices
343
Adverse events
3
Recalls
19
510(k) clearances
Devices with this code
Equinoxe — Exactech, Inc.OsseoFit™ Stemless Shoulder — Zimmer, Inc.Tornier Simpliciti® Shoulder System — TORNIER, INC.Simpliciti™ — TORNIER, INC.OsseoFit™ Stemless Shoulder — Zimmer, Inc.Comprehensive® Shoulder System — Biomet Orthopedics, LLCComprehensive® Shoulder System — Biomet Orthopedics, LLCArthrex® — ARTHREX, INC.GLOBAL ICON — DEPUY (IRELAND)GLOBAL ICON — DEPUY (IRELAND)AETOS Shoulder System — Smith & Nephew, Inc.Simpliciti™ — TORNIER, INC.SMR STEMLESS — LIMACORPORATE SPAGLOBAL ICON — DEPUY (IRELAND)DJO SURGICAL — Encore Medical, L.P.DJO SURGICAL — Encore Medical, L.P.SMR STEMLESS — LIMACORPORATE SPAOsseoFit™ Stemless Shoulder — Zimmer, Inc.Equinoxe — Exactech, Inc.SMR STEMLESS — LIMACORPORATE SPAEquinoxe — Exactech, Inc.GLOBAL ICON — DEPUY (IRELAND)Comprehensive® Shoulder System — Biomet Orthopedics, LLCEquinoxe — Exactech, Inc.
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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