Recall Z-1973-2019
SpineFrontier, Inc. · initiated June 13, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
Codes / lots: Lot EC20
Reason for recall
There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.
FDA-determined cause: Process control
Action taken
Urgent Medical Device Recall letters dated 6/13/19 were emailed to customers.
Details
- Recall number
- Z-1973-2019
- Initiated
- June 13, 2019
- Terminated
- May 11, 2020
- Product code
- OVE – Intervertebral Fusion Device With Integrated Fixation, Cervical
- Quantity
- 6
- Distribution
- The products were distributed to the following US states: AZ, MD, MO, and FL.
- Recalling firm
- SpineFrontier, Inc., Malden, MA