Home / Recalls / Medical Devices
CTL Medical Corporation recalls CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
Recalled March 27, 2019 · FDA recall Z-1030-2019 · CTL Medical
Hazard
the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening. if the anti-toggle ring remains in the pedicle crew head and can interfere with final tightening of the pedicle screw construct. this can lead to failure of the set crew and relies of the rod from the construct. · FDA Class II
Units
133 total devices
Sold at
distributor and user level
Description
the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening. if the anti-toggle ring remains in the pedicle crew head and can interfere with final tightening of the pedicle screw construct. this can lead to failure of the set crew and relies of the rod from the construct.
Product
CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
Manufacturer(s)
CTL Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →