Z-3198-2026 Class II Ongoing
FDA device recall Z-3198-2026 was initiated by Howmedica Osteonics Corp. on July 30, 2026 and is designated Class II. Reason for recall: 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 m… The recall status is ongoing. Affected quantity: 12,156 US.
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2026
- Initiation Date
- July 30, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,156 US
Product Description
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)
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
Code Information
5612-P-411 UDI-DI 07613327601893 Lot 360958 5612-P-413 UDI-DI 07613327602012 Lot 354573