FDAMarch 5, 2015device
SpineFrontier 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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use of the design.
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.
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