Health product recall

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

Brand(s)
Last updated

Summary

Product
Nexgen Complete Knee Solution Stemmed Non-Augment Tibial Comp (Cr/Ps) Option
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Nexgen Complete Knee Solution Stemmed Non-Augment Tibial Comp (Cr/Ps) Option More than 10 numbers, contact manufacturer. 00598603701 00598604702 00598605701 00598603702 00598604701 00598605702

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

 

 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Orthopaedics
Companies

Zimmer Inc.

1800 West Center Street, Warsaw, Indiana, United States, 46580

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72402