FDA-Device2019-07-24Class II
A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
SpineFrontier, Inc.
Hazard
There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.
Sold states
The products were distributed to the following US states: AZ, MD, MO, and FL.
Affected count
6
Manufactured in
350 Main St, N/A, Malden, MA, United States
Products
A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1973-2019Don't want to check this manually?
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