Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | October 29, 2025 |
| Reported | January 21, 2026 |
| Recalling firm | Medicrea International |
| Country / region | France US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA. |
Hazard
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Affected products
- Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
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