Howmedica Osteonics SCORPIO patella implants recalled for premature wear risk
What this means
Howmedica Osteonics manufactured SCORPIO recessed metal-backed patella implants using polyethylene material that was stored longer than five years before use. This aged material can develop oxidation, which may cause the implant to wear faster than expected, potentially leading to device failure, fractures, or loosening.
- If you received one of these implants, contact your surgeon or healthcare provider with your device lot number to determine if yours is affected.
- Your doctor may recommend imaging or monitoring to assess the implant's condition.
- Do not attempt to remove or replace the device yourself; only a qualified surgeon should manage any needed revision.
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-3203-2026More Howmedica Osteonics recalls
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