Official recall record

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

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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