Howmedica Osteonics shoulder implant components recalled for accelerated wear risk
What this means
Certain Howmedica Osteonics shoulder implant components were made with aged polyethylene material that can develop excessive oxidation. This may cause the implant to wear faster than expected, potentially leading to device fracture or loosening, material fragments, and the need for revision surgery.
- If you received one of these implants, contact your surgeon or orthopedic care provider with your device lot number
- Do not stop using your implant without medical guidance
- Your provider can determine if your specific implant is affected and discuss monitoring or replacement options
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-3200-2026More Howmedica Osteonics recalls
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