NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM — Class II medical device recall Z-1264-2024
Ongoing recall by Howmedica Osteonics Corp., reported 2024-03-13, distributed nationwide. Potential packaging breaches of inner blister and outer sterile blister.
| Recall number | Z-1264-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2024-02-06 |
| Classified | 2024-03-06 |
| Reported by FDA | 2024-03-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CL, CO, JP, KR |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 07613327287691 |
| Lot numbers | E97TH6 |
| Model numbers | 5537-G-411-E |
| Expiration dates | 2028-10-07 |
Product
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Reason for recall
Potential packaging breaches of inner blister and outer sterile blister.
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-1264-2024. 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.