Howmedica Osteonics Scorpio knee implant patella components recalled for oxidation and wear risk
What this means
Howmedica Osteonics knee implant patella components (Scorpio C-Dome and U-Dome models) were made with plastic material that had aged longer than intended. This aging can cause the material to break down faster than expected, leading to excessive wear, debris, or even device fracture inside the knee.
- If you have had one of these knee implants placed, contact your orthopedic surgeon with your device model number and lot number.
- Your surgeon can review imaging and symptoms to determine if your implant is affected and whether monitoring or revision surgery is needed.
- Do not stop normal activities based on this notice alone; your doctor will advise next steps.
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-3206-2026More Howmedica Osteonics recalls
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