Home / Recalls / Zimmer, Inc. / Z-0468-2023

Z-0468-2023 Class II Ongoing

Recalled by Zimmer, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
December 21, 2022
Initiation Date
December 6, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2460

Product Description

NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01

Reason for Recall

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.

Distribution Pattern

Worldwide - US Nationwide distribution.

Code Information

All Unexpired Lots

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