Zimmer, Inc. has recalled 5,546 units of the NexGen CR-Flex Femoral Component (Sizes E and E-), which are part of the NexGen CR-Flex Porous Femur System used in knee replacement surgeries. The recall was initiated because a manufacturing error resulted in a gap within the fixture that presses the fiber metal pad to the device base, preventing the pad from fully bonding. These affected orthopedic implants were distributed worldwide, including 30 US states, between 2024 and 2034 according to tracking codes. Because these are surgical implants, you should contact your healthcare provider or orthopedic surgeon if you have concerns about your knee replacement.
If the metal pad is not fully bonded to the implant, it may detach or fail to integrate properly with the bone. This could lead to implant loosening, joint instability, or the need for a premature follow-up surgery to replace the defective component.
Medical Device Manufacturer Action
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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