Offset Cup Impactor — Class II medical device recall Z-0549-2025
Ongoing recall by INCIPIO DEVICES, reported 2024-12-04, distributed nationwide. Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
| Recall number | Z-0549-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | INCIPIO DEVICES, St-Blaise, Switzerland |
| Recall initiated | 2024-10-30 |
| Classified | 2024-11-25 |
| Reported by FDA | 2024-12-04 |
| Distributed | Nationwide (US) |
| Quantity | 100 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 07630055304735 |
| Lot numbers | 24A0087 |
Product
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Reason for recall
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
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-0549-2025. 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.