FDA Medical devices recall ·
TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE… recall
- Recall number
- Z-3198-2026
- Date
- (initiated July 30, 2026)
- Company / brand
- Howmedica Osteonics Corp.
325 Corporate Dr, Mahwah, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 12,156 US
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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)
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3198-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.