The Recall Desk
HighFDA (Devices)·Z-1653-2023·Announced 2023-06-07

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.

What this means for you

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.
Category
Medical Device — Orthopedic Implant
Hazard
  • mis-labeling
  • wrong-implant-size

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

Distributed nationwide across the United States.

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