Device recall
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)
- Recall number
- Z-3198-2026
- Event id
- 99558
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Howmedica Osteonics Corp.
- Report date
- Sep 23, 2026
- Posted
- Sep 16, 2026
- Initiated
- Jul 30, 2026
- Center classification date
- Sep 16, 2026
- Product code
- KRO
- Device type
- Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- Reason
- 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.
- Root cause
- Process change control
- Quantity
- 12,156 US
- Code info
- 5612-P-411 UDI-DI 07613327601893 Lot 360958 5612-P-413 UDI-DI 07613327602012 Lot 354573
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K223528
- Location
- Mahwah, NJ, United States