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

Recall date

June 13, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1973-2019

FDA classification

Class II

Brand / firm

SpineFrontier, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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