FDA-Device2019-03-27Class II
CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
CTL Medical Corporation
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.
Sold states
distributor and user level
Affected count
133 total devices
Manufactured in
4550 Excel Pkwy Ste 300, N/A, Addison, TX, United States
Products
CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1030-2019Don't want to check this manually?
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