CTL Medical Hex Driver recall
CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
Why was CTL Medical Hex Driver 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 7EQAB-D, 7ATAB-D
- Product
- CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
- Recalling firm
- CTL Medical Corporation
- Quantity
- 133 total devices
- Distribution
- distributor and user level
- Recall date
- March 27, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)