FDA recall Z-1973-2019

SpineFrontier, Inc. · Class II · device

Product

A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)

Reason for recall

There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.

Distribution

The products were distributed to the following US states: AZ, MD, MO, and FL.

Key facts

Status
Terminated
Initiation date
2019-06-13
Report date
2019-07-24
Termination date
2020-05-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Malden, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1973-2019