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LINK Embrace Shoulder System
WALDEMAR LINK GmbH & Co. KG · Model 643-236/06 · UDI-DI 04026575237685
1
510(k) clearances
755
Adverse events (1 deaths)
3
Recalls
69
Facilities
Description
Reverse Inserts, neutral, E-Dur
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 seating in the stem |
| 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 slot on the resection g |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.