Howmedica Osteonics elbow implant axle pin recalled for premature wear and fracture risk
What this means
Howmedica Osteonics manufactured certain elbow implant axle pins using aged polyethylene material that can develop excessive oxidation over time. This may cause the device to wear prematurely, crack, or break apart inside the body, potentially requiring revision surgery.
- If you have received this implant, contact your surgeon or orthopedic provider to confirm whether your device is affected.
- Do not remove or discontinue use of the implant without medical guidance.
- Report any pain, swelling, or implant-related symptoms to your healthcare provider immediately.
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-3195-2026More Howmedica Osteonics recalls
- FDA-Device2026-09-23Howmedica Osteonics Triathlon Hinge Insert recalled for premature wear risk
- FDA-Device2026-09-23Howmedica Osteonics SCORPIO patella implants recalled for premature wear risk
- FDA-Device2026-09-23Howmedica Osteonics orthopaedic implant components recalled for premature wear risk
- FDA-Device2026-09-23Howmedica Osteonics hip implant components recalled for premature wear risk
- FDA-Device2026-09-23Howmedica Osteonics shoulder implant components recalled for accelerated wear risk
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.