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Nexgen cr-flex femoral component, size e and size e minus (e-)
Official notice
17 Apr 2024
Last checked
17 Apr 2024
An official Health Canada notice concerns Nexgen cr-flex femoral component, size e and size e minus (e-). 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 Published 2024-04-17.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75403
Official notice
2024-04-17
The hazard
The hazard
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
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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Brand: Zimmer, Nexgen Cr-flex Femoral Component Size E And Size E Minus.
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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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