Device product
A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
Z-1973-2019
Product summary
- Event
- Event 83166
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6
- Official record key
device-enforcement:Z-1973-2019
Official wording
Reason: There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.
Code information: Lot EC20
Distribution pattern: The products were distributed to the following US states: AZ, MD, MO, and FL.
Derived failure modes
-
Unknown
There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.