FDA DevicesClass II
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Published: January 21, 2026Recall ID: Z-1039-2026Category: devicesCountry: US
Reason for Recall / Hazard
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Product Description & Identification
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Affected Products
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Additional Source Details
| Field | Value |
|---|---|
| City | Rillieux La Pape |
| Event id | 97996 |
| Address 1 | 5389 route de Strasbourg |
| Address 2 | Vancia |
| Code info | Lot# 0001, 0002, 0003, 0004, 0005, 0006, 0008, 0009, 0010, 0011, 0012, 0013, 0014, 0016 ,0017 ,0018, 0020, 0021, 0024, 0025, 0026, 0029/UDI: SPS03174 |
| Postal code | N/A |
| Report date | 20260121 |
| Product type | Devices |
| Product quantity | 44 units |
| Reason for recall | Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251029 |
| Initial firm notification | Letter |
| Center classification date | 20260109 |
Overview
- Recalling FirmMedicrea International
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.