CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
Published March 27, 2019 · Recall initiated: July 5, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- CTL Medical Corporation
- Distributor
- distributor and user level
- Lot
- Lot 7EQAB-D, 7ATAB-D
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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