1 — Class II medical device recall Z-2640-2025
Ongoing recall by Howmedica Osteonics Corp., reported 2025-10-08. a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalo
| Recall number | Z-2640-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2025-08-28 |
| Classified | 2025-09-26 |
| Reported by FDA | 2025-10-08 |
| Countries outside the US | GB |
| Quantity | 55 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04546540153241, 04546540153319 |
| Lot numbers | A00976, G8754849 |
| Model numbers | 0580-1-352, 0580-1-442 |
Product
1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;
Reason for recall
a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.
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-2640-2025. 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.