Biolox delta Ceramic V40 Femoral Head 32/ +4 — Class II medical device recall Z-0843-2022
Ongoing recall by Howmedica Osteonics Corp., reported 2022-04-06, distributed nationwide. Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the pac
| Recall number | Z-0843-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2022-01-14 |
| Classified | 2022-03-31 |
| Reported by FDA | 2022-04-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, CN, DE, ES, GB, JP, NL |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04546540608536 |
| Lot numbers | 89546202 |
| Model numbers | 6570-0-232 |
Product
Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
Reason for recall
Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling
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-0843-2022. 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.