Howmedica Osteonics orthopedic knee implant components recalled for material oxidation and wear risk
What this means
Howmedica Osteonics manufactured multiple knee implant components (inserts, bearings, and patella components) using polyethylene material that was stored for more than five years before use. The aged material may have developed excessive oxidation, which can cause the implant to wear faster than intended and potentially break apart inside the body.
- If you have one of the affected implant components, contact your surgeon or healthcare provider immediately with your implant model number and lot number.
- Do not remove the implant yourself; work with your medical team to determine if replacement is needed.
- Keep implant documentation and lot numbers available for your healthcare provider.
The agency's original wording
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3197-2026Also reported as
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