TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision… — Class II medical device recall Z-1625-2024
Ongoing recall by Howmedica Osteonics Corp., reported 2024-05-01, distributed nationwide. The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
| Recall number | Z-1625-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2024-02-27 |
| Classified | 2024-04-25 |
| Reported by FDA | 2024-05-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, ES, GB, NL, SE, SG |
| Quantity | 225 units |
| UPC / GTIN / UDI-DI | 07613327380880 |
| Lot numbers | 15293151, 15293152, 15293153, 15432251, 15432252, 15432253, 15432254, 15432351, 15432451, 16265752 |
| Model numbers | 702-11-54E |
Product
TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54E
Reason for recall
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
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-1625-2024. 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.