Howmedica Recalls Triathlon Hinge Inserts Due to Material Aging
Howmedica is recalling Triathlon hinge inserts made with aged polyethylene that may wear excessively, potentially causing device fracture or the need for revision surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where the hazard (device fracture, revision surgery) is a potential risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria.
Plain-English summary
Howmedica Osteonics Corp. is recalling specific Triathlon hinge insert components (sizes 4, 11mm and 13mm) manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The affected devices were produced using raw material that had aged for more than five years.
The aged material has the potential for elevated levels of oxidation, which may result in increased wear. This excessive wear can lead to hazards such as excessive wear debris, material fragments, fractured devices, or disassociated devices. Potential harms to patients include the need for revision surgery, pain, and inflammation.
The recall involves 12,156 units distributed worldwide, including the United States, Canada, LATAM, Europe, Asia Pacific, and South Africa. Affected lot numbers are 360958 (for 5612-P-411) and 354573 (for 5612-P-413). Patients and healthcare providers should contact Howmedica or their orthopaedic surgeon to determine if they have the affected implants and to discuss appropriate clinical management.
The recalled product
- 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)
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 12,156
Distribution
Distributed nationwide across the United States.
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