Zimmer recalls NexGen CR-Flex Femoral Components (Size E and E-) due to a gap in metal bonding that could cause failure. Affected items have specific UDI codes listed in the recall.
Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.
Zimmer is recalling NexGen CR-Flex Femoral Components (Size E and E-) because a manufacturing defect causes gaps in the metal bonding. This could lead to component failure during surgery. Affected items have specific UDI codes listed in the recall.
The components have a gap in the bonding between the fiber metal pad and substrate due to an out-of-specification violation. This gap could cause the pad to not fully bond, potentially leading to component failure during surgery.
Orthopedic surgeons and medical facilities that use Zimmer's NexGen CR-Flex Porous Femur System components. The risk is low as this is a manufacturing defect that may not cause immediate failure.
Check if your NexGen CR-Flex Femoral Component (Size E or E-) has the specific UDI codes listed in the recall, which include a range of lot numbers starting with 64115713 and ending with 66378834.
Look for the UDI codes listed in the recall (e.g., 64115713, 64175075, etc.) on the product.
NexGen CR-Flex Femoral Components (Size E and E-) as part of the NexGen CR-Flex Porous Femur System.
Check if your product has the specific UDI codes listed in the recall, which include a range of lot numbers starting with 64115713 and ending with 66378834.
The recall record shows no remedy was specified.
We’ve drafted a message you can send Zimmer to request your refund or repair — edit it as you like.
Subject: Recall Z-1608-2024 — Zimmer Zimmer Hello, I own a Zimmer that is covered by recall Z-1608-2024 from Zimmer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
