medical Class II Updated 2019-03-27

CTL Medical Corporation recalls CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref

Recalled Product

CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050


Hazard / Issue

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.

Issued by

FDA

Distribution: distributor and user level
Lot/Code Info: Lot 7EQAB-D, 7ATAB-D
View official government recall

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