Device product
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Z-1038-2026
Product summary
- Event
- Event 97996
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 44 units
- Official record key
device-enforcement:Z-1038-2026
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# 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, 21J1027/ UDI: (01)03613720286677
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.