Triathlon Tritanium Tibial Components Recalled for Size-Packaging Mismatch
Howmedica Osteonics is recalling specific lots of Triathlon Tritanium Tibial Components (knee implants) due to a potential mismatch between package labeling and the actual component size contained inside.
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: This is an FDA Class II recall of an orthopedic implant involving a product mix where package contents do not match labeling. No illnesses or injuries are reported in the source material, but a size mismatch in joint prosthetics presents a risk of improper surgical outcomes and potential revision surgery.
Plain-English summary
Howmedica Osteonics Corp. is recalling specific lots of Triathlon Tritanium Tibial Components (Sizes 5 and 6, catalog numbers 5536-B-500 and 5536-B-600) worldwide due to a potential product mix where the size of the tibial component inside the package does not match the package labeling.
A mismatch between the labeled size and the actual component size could result in an incorrect prosthetic component being implanted during surgery. This may compromise the fit and function of the knee replacement and could necessitate revision surgery or other corrective intervention.
The recall affects 22 units total: 12 units distributed in the United States across Alabama, California, Colorado, Idaho, Indiana, Kansas, Michigan, Nevada, Pennsylvania, Tennessee, Washington, and West Virginia, and 10 units distributed internationally to the United Kingdom and Poland. Healthcare providers and patients who have received these components should verify that the implanted device matches the surgical intention and contact their surgeon immediately if they have concerns about component size or fit.
The recalled product
- Product
- Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
- Manufacturer
- Howmedica Osteonics Corp.
Distribution
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