Drug recall
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
FDA recall event 97996 · Class II · Medicrea International
Key facts
| Event ID | 97996 |
|---|---|
| Recall numbers | Z-1038-2026, Z-1039-2026 |
| Recalling firm | Medicrea International |
| Product type | Devices |
| Products | Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174, Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. |
| Initiation date | Oct 29, 2025 |
| Report date | Jan 21, 2026 |
| City | Rillieux La Pape |
| Country | France |
| FEI number | 1000432246 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: