Zimmer, Inc. has recalled 1,116 Zimmer Biomet Ceramic Femoral Heads (22.2 mm Diameter) because the product labeling fails to provide necessary compatibility information for use with cobalt-chrome or stainless-steel femoral stems. Using incompatible surgical components during a hip replacement can lead to device failure or require the patient to undergo additional surgery. No injuries or incidents have been reported to date.
The inadequate labeling may lead surgeons to pair the ceramic femoral head with an incompatible metal stem, which can cause increased wear, component fracture, or other mechanical failures in the hip prosthesis. These complications would likely require revision surgery to correct.
All lots distributed with IFU 87-6204-051-99 Rev D or prior.
All lots distributed with IFU 87-6204-051-99 Rev D or prior.
All lots distributed with IFU 87-6204-051-99 Rev D or prior.
All lots distributed with IFU 87-6204-051-99 Rev D or prior.
All lots distributed with IFU 87-6204-051-99 Rev D or prior.
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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