Howmedica Osteonics TRIDENT poly insert recalled for premature wear risk
What this means
Howmedica Osteonics TRIDENT 0° poly insert knee implants (model 620-00-28D) were made with aged polyethylene material that can break down faster than intended. This may cause the implant to wear excessively, crack, or loosen inside the knee, potentially requiring revision surgery.
- If you received this implant, contact your surgeon or physician to discuss whether monitoring or replacement is appropriate.
- Ask your doctor about your implant lot number (MHANP2 or MHD1N0) to confirm if yours is affected.
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-3204-2026More Howmedica Osteonics recalls
- FDA-Device2026-09-23Howmedica Osteonics OMNIFIT Series I acetabular insert recalled for elevated oxidation and wear risk
- FDA-Device2026-09-23Howmedica Osteonics hip and knee implant components recalled for premature wear risk
- FDA-Device2026-09-23Howmedica Osteonics Scorpio knee implant patella components recalled for oxidation and wear risk
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