TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee… — Class II medical device recall Z-1653-2023
Ongoing recall by Howmedica Osteonics Corp., reported 2023-06-07, distributed nationwide. Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Ca
| Recall number | Z-1653-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2023-04-13 |
| Classified | 2023-05-30 |
| Reported by FDA | 2023-06-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, JP |
| Quantity | 24 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 07613327390698 |
| Lot numbers | JH3AHJ |
| Model numbers | 5531-G-312-E |
Product
TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
Reason for recall
Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1653-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.