Medicrea — Class II medical device recall Z-1039-2026
Ongoing recall by Medicrea International, reported 2026-01-21, distributed nationwide. Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to ro
| Recall number | Z-1039-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medicrea International, Rillieux La Pape, France |
| Recall initiated | 2025-10-29 |
| Classified | 2026-01-09 |
| Reported by FDA | 2026-01-21 |
| Distributed | Nationwide (US) |
| Quantity | 44 units |
| Lot numbers | 0001, 0002, 0003, 0004, 0005, 0006, 0008, 0009, 0010, 0011, 0012, 0013, 0014, 0016, 0017, 0018, 0020, 0021, 0024, 0025, 0026, 0029 |
| Model numbers | SPS03174 |
Product
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Reason for recall
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
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-1039-2026. 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.