Knee replacement implant bearing inserts mislabeled with wrong catalog numbers
Howmedica Osteonics recalled 24 TRIATHLON X3 tibial bearing inserts due to mislabeling, where units labeled with one catalog number may contain a different size. Medical facilities should discontinue use and contact the manufacturer.
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 a mislabeled surgical implant, which qualifies as a risk-of-harm product where injury has not yet been reported—the rubric criterion for High severity. The source documents the labeling error but contains no reports of illnesses, injuries, or adverse clinical outcomes.
Plain-English summary
Howmedica Osteonics Corp. is recalling TRIATHLON X3 TIBIAL BEARING INSERT units intended for knee replacement surgery. The affected product carries catalog number 5531-G-312-E (CS #3, 12MM), and a total of 24 units from lot number JH3AHJ are involved in the recall.
The critical issue is mislabeling. Units labeled with catalog number 5531-G-312-E (CS #3, 12MM) may actually contain the specifications of catalog number 5532-G-413-E (PS #4, 13MM), and vice versa. This means some implants contain the wrong size bearing surface.
The risk is that surgical teams, relying on the label, could implant the incorrect size during knee replacement surgery. If a wrong-size bearing insert is implanted, it could result in improper fit and compromise the function and longevity of the surgical repair.
Affected medical facilities are located in Connecticut, Florida, Indiana, Kentucky, Montana, New Jersey, Oregon, Pennsylvania, and South Carolina, with international distribution to China and Japan. Medical professionals should immediately discontinue use of affected implants from lot JH3AHJ and contact Howmedica Osteonics Corp. for replacement instructions and additional information.
The recalled product
- Product
- TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
- Manufacturer
- Howmedica Osteonics Corp.
- 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: 07613327390698 Lot Number: JH3AHJ
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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