Howmedica Osteonics orthopaedic implant components recalled for elevated oxidation risk
What this means
Howmedica Osteonics Corp. is recalling multiple orthopaedic implant components (acetabular inserts, tibial inserts, bushings, and other joint replacement parts) manufactured with polyethylene material that was aged more than five years before use. This aged material can develop excessive oxidation, which increases the risk of accelerated wear, material fragmentation, or device failure inside the body.
- Contact your surgeon or orthopedic clinic if you have received one of these implants and ask whether your device is affected based on the product model and lot number.
- Do not remove or attempt to replace an implant on your own; only a surgeon should do this.
- Seek medical attention if you experience unusual pain, swelling, or loss of implant function.
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-3199-2026More Howmedica Osteonics recalls
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.