Home › Device types › PAO
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
FDA product code PAO · Class 2 · Orthopedic
1,427
Registered devices
755
Adverse events
3
Recalls
1
510(k) clearances
Devices with this code
Identity® Shoulder System — Zimmer, Inc.Tornier Perform Humeral System — TORNIER, INC.Comprehensive® Reverse Shoulder — Biomet Orthopedics, LLCPRIMA — LIMACORPORATE SPADJO SURGICAL — Encore Medical, L.P.PRIMA — LIMACORPORATE SPAComprehensive — Biomet Orthopedics, LLCPERFORM™ HUMERAL SYSTEM — TORNIER, INC.LINK Embrace Shoulder System Line Extension — WALDEMAR LINK GmbH & Co. KGDJO SURGICAL — Encore Medical, L.P.TORNIER PERFORM™ HUMERAL SYSTEM — TORNIER, INC.Comprehensive® Reverse Shoulder — Biomet Orthopedics, LLCComprehensive® SRS Instrument — Biomet Orthopedics, LLCLINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KGCOMPREHENSIVE REVERSE SHOULDER — Biomet Orthopedics, LLCINHANCE — DEPUY (IRELAND)COMPREHENSIVE INSTRUMENTATION — Biomet Orthopedics, LLCTornier Perform Humeral System — TORNIER, INC.Comprehensive® Versa-Dial® — Zimmer, Inc.LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KGLINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KGPERFORM™ HUMERAL SYSTEM — TORNIER, INC.COMPREHENSIVE REVERSE SHOULDER — Biomet Orthopedics, LLCComprehensive — Biomet Orthopedics, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-29 | Tornier, Inc | Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely |
| 2016-12-20 | Zimmer Biomet, Inc. | Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing. |
| 2013-05-15 | Biomet, Inc. | Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slo |
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