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Zimmer, Inc. recalls NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02

Recalled December 21, 2022 · FDA recall Z-0469-2023 · Zimmer

Hazard
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. · FDA Class II
Units
1366
Sold at
Worldwide - US Nationwide distribution.

Description

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.

Product
NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02
Manufacturer(s)
Zimmer, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Zimmer, Inc. recalls NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02 | RecallWatchUSA