Knee Replacement Insert Mislabeled; Contents May Not Match Catalog Number
Howmedica Osteonics Corp. is recalling TRIATHLON X3 knee replacement bearing inserts because products labeled with one catalog number may actually contain a different specification. This mislabeling could result in incorrect implant sizing during 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: This FDA Class II recall involves mislabeling of knee replacement implant components that could result in incorrect product use during surgery. Although no illnesses or injuries have been reported, the potential for implant sizing mismatch poses a risk of harm to patient outcomes.
Plain-English summary
Howmedica Osteonics Corp. is recalling TRIATHLON X3 TIBIAL BEARING INSERT products (lot 7H8RPL). Products labeled with Catalog Number 5531-G-312-E (CS #3 12MM) may actually contain Catalog Number 5532-G-413-E (PS #4 13MM), and vice versa.
This mislabeling issue affects knee replacement procedures, as using an incorrectly sized or specified bearing insert could compromise surgical outcomes. The recall involves 24 units distributed across the United States (Connecticut, Florida, Indiana, Kentucky, Montana, New Jersey, Oregon, Pennsylvania, South Carolina) and internationally in China and Japan.
The FDA has classified this as a Class II recall. Healthcare providers who received products from lot 7H8RPL should verify the actual contents of their inventory to ensure the product specifications match the catalog numbers on the labels.
The recalled product
- Product
- TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- Affected units
- 24
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 07613327338560 Lot Number: 7H8RPL
Distribution
Part of a larger recall action
This product is one of 2 recalled by Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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