Health product recall

Nexgen CR-Flex Femoral Component, Size E And Size E Minus (E-)

Brand(s)
Last updated

Summary

Product
Nexgen CR-Flex Femoral Component, Size E And Size E Minus (E-)
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Nexgen CR-Flex Femoral Component, Size E And Size E Minus (E-)

More than 10 numbers, contact manufacturer.

00-5952-015-06
00-5952-015-02
00-5952-015-05
00-5952-015-01

Issue

Zimmer Biomet is conducting a lot specific medical device recall for Nexgen CR-flex femoral components, size E and size E minus (E-) . This recall is due to an out of specification violation that was observed in samples for the tensile feature during process monitoring. The investigation determined the root cause to be isolated and limited to manufacturing process for the Nexgen CR-flex size E and size E- femoral components, where a gap could exist within the fixture that presses the fiber metal pad to the substrate. This gap may potentially cause the pad to not fully bond to the substrate, leading to the tensile specification failure. There have been no complaints related to the issue description reported.

Recall start date: April 5, 2024

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-75403

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