Howmedica Osteonics OMNIFIT Series I acetabular insert recalled for elevated oxidation and wear risk
What this means
Howmedica Osteonics recalled certain OMNIFIT Series I acetabular inserts (Catalog No. 2001-2246) because the polyethylene material used was aged beyond recommended limits. This aging can cause increased oxidation and premature wear, potentially leading to device fragments, fracture, or loosening inside the body.
- Contact your surgeon or orthopedic provider immediately if you have had a hip replacement using this implant (check your surgical records for Catalog No. 2001-2246 or Lot 13MFT).
- Do not delay—discuss whether monitoring or revision surgery may be needed.
- Report any hip pain, swelling, clicking, or instability to your doctor right away.
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-3196-2026More Howmedica Osteonics recalls
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