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Zimmer, Inc. Recall 91073

Description: NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02

Zimmer, Inc. Recall 91073 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0469-2023
Event ID91073
Event DescriptionNexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02
Product TypeDevices
DistributionWorldwide - US Nationwide distribution.
Quantity1366
Recall ReasonZimmer 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.
Device Classification20221221
Device Code InfoAll Unexpired Lots
Center Classification Date20221209
Recall Initiation Date20221206
Recalling FirmZimmer, Inc.
Initial Notification Letter
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