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