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Nexgen complete knee solution stemmed non-augment tibial comp (cr ps) option
Official notice
22 Dec 2022
Last checked
22 Dec 2022
An official Health Canada notice concerns Nexgen complete knee solution stemmed non-augment tibial comp (cr ps) option. 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 Published 2022-12-22.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72402
Official notice
2022-12-22
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
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Affected products
Product 1
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
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Company & contacts
Company & contacts
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Manufacturer
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Brand: Zimmer, Nexgen Complete Knee Solution Stemmed Non-augment Tibial Comp Option.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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