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LINK Embrace Shoulder System Line Extension

WALDEMAR LINK GmbH & Co. KG · Model 645-074/25 · UDI-DI 04026575533527

PAO PHX Prescription

510(k) clearances

755

Adverse events (1 deaths)

Recalls

Facilities

Description

Bone Screws, and Cancellous Bone Screw

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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Data 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.