FDAFDA · Food and drugs·Recall number Z-1973-2019
A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
Published July 24, 2019 · Recall initiated: June 13, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SpineFrontier, Inc.
- Distributor
- The products were distributed to the following US states: AZ, MD, MO, and FL.
- Lot
- Lot EC20
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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