Device product
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Z-1039-2026
Product summary
- Event
- Event 97996
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 44 units
- Official record key
device-enforcement:Z-1039-2026
Official wording
Reason: Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
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
Distribution pattern: US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.
Derived failure modes
-
Unknown
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.