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

Recall date

July 5, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1030-2019

FDA classification

Class II

Brand / firm

CTL Medical Corporation

Sold / distributed

distributor and user level

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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