Howmedica Osteonics orthopaedic implant components recalled for premature wear risk
What this means
Certain orthopaedic implant components (bearing and axle bushings, tibial inserts, and glenoid components) were manufactured with aged raw material that may have elevated oxidation levels. This can lead to increased wear, material fragments, or device fracture.
- If you have received one of these implants, contact your surgeon or healthcare provider with your device lot number.
- Do not remove the implant yourself; discuss any symptoms (pain, inflammation, swelling) with your doctor.
- Ask your surgeon whether monitoring or replacement is recommended.
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-3202-2026More Howmedica Osteonics recalls
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