TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-413 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Published September 23, 2026 · Recall initiated: July 30, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Howmedica Osteonics Corp.
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
- Lot
- 5612-P-411 UDI-DI 07613327601893 Lot 360958 5612-P-413 UDI-DI 07613327602012 Lot 354573
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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