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

Recall Z-0468-2023 — NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01

U.S. FDA — Device Enforcement · United States · 2022-12-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0468-2023
Date of alert
2022-12-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer, Inc.
Product category
device
Product type
Devices
Reported risk: Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry (UK NJR). Removing the NexGen Stemmed Option Tibial Component f rom inventory will prevent its future implantation with either the LPS Flex or LPS Flex GSF femoral components and mitigate the increased revision risk with these two specific combinations of tibial and femoral component.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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