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Health Canada Medical devices

Nexgen Complete Knee Solution Stemmed Non-Augment Tibial Comp (Cr/Ps) Option

Issued December 22, 2022
Issue
Zimmer Biomet is conducting a medical device recall for Nexgen stemmed cemented option tibial trays 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 from 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. Recall start date: December 13, 2022
Hazard description
Performance
Product
Product name
Nexgen Complete Knee Solution Stemmed Non-Augment Tibial Comp (Cr/Ps) Option
Reference
ID
RA-72402