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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

Medium riskHealth Canada
Watch Zimmer

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

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

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

72402

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Affected products

Product 1

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

Risk / 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

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Zimmer, Nexgen Complete Knee Solution Stemmed Non-augment Tibial Comp Option

Manufacturer

Not provided

Phone

Not provided

Brand: Zimmer, Nexgen Complete Knee Solution Stemmed Non-augment Tibial Comp Option.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

72402

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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