FDAJune 13, 2019device
A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.
What to do
FDA enforcement status: Terminated
Brands named
spinefrontier
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDASpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive surgical (MIS) techn...2015-03-05
- FDAlnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-801642014-12-19
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