Recall Z-1973-2019 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
SpineFrontier, Inc.
A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
| Date | Jun 13, 2019 |
| Status | Terminated |
| Reason | There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw. |
| Root cause | Process control |
| Action | Urgent Medical Device Recall letters dated 6/13/19 were emailed to customers. |
| Quantity | 6 |
| Distribution | The products were distributed to the following US states: AZ, MD, MO, and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172484 | A-CIFT SoloFuse Spinefrontier, Inc., May 8, 2018 |