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

Recall Z-1671-2023 — Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6); Unicondylar knee prothesis

U.S. FDA — Device Enforcement · United States · 2023-05-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1671-2023
Date of alert
2023-05-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Smith & Nephew, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00885556873083
Reported risk: Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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