Z-1039-2026 Class II Ongoing
FDA device recall Z-1039-2026 was initiated by Medicrea International on October 29, 2025 and is designated Class II. Reason for recall: Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. The recall status is ongoing. Affected quantity: 44 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 21, 2026
- Initiation Date
- October 29, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44 units
Product Description
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.
Distribution Pattern
US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.
Code Information
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