Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0749-2024 — Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05

U.S. FDA — Device Enforcement · Germany · 2023-11-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0749-2024
Date of alert
2023-11-30
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
Waldemar Link GmbH & Co. KG (Mfg Site)
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04026575245253
Reported risk: Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to extended surgery time
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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