PlainRecalls
FDA Devices Moderate Class II Ongoing

NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02

Reported: December 21, 2022 Initiated: December 6, 2022 #Z-0467-2023

Product Description

NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02

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.

Details

Recalling Firm
Zimmer, Inc.
Units Affected
2092
Distribution
Worldwide - US Nationwide distribution.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled? ▼
NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02. Recalled by Zimmer, Inc.. Units affected: 2092.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 21, 2022. Severity: Moderate. Recall number: Z-0467-2023.

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