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

Recall Z-0631-2022 — ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003

U.S. FDA — Device Enforcement · United States · 2022-01-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0631-2022
Date of alert
2022-01-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
DePuy Orthopaedics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10603295383178
Reported risk: May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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