CTL Medical recalls 1/4" Square QC Hex Drivers with serial numbers 7EQAB-D and 7ATAB-D due to risk of anti-toggle ring separating during surgery, potentially causing screw failure.
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.
CTL Medical is recalling specific hex drivers used in surgery because the anti-toggle ring might detach during use. This could cause screws to become loose or fail, which might affect surgical stability.
The anti-toggle ring can separate from the driver shaft during surgery. If it remains in the screw head, it may interfere with proper tightening, leading to screw failure and potential instability in the surgical construct.
Surgical teams using the recalled hex drivers for spinal procedures are most at risk. Patients undergoing spinal surgery with these tools may face complications from unstable screw fixation.
Check for the model '1/4" Square QC, 4..0 Ratcheting' with serial numbers 7EQAB-D or 7ATAB-D. These drivers were sold by CTL Medical Corporation.
Look for serial numbers 7EQAB-D or 7ATAB-D on the hex driver packaging or product.
The recalled model is CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050 with serial numbers 7EQAB-D or 7ATAB-D.
If the anti-toggle ring separates, it may press into the pedicle screw head and cause the screw to become loose or fail during tightening, potentially leading to instability in the surgical construct.
The recall does not specify an immediate stop-use action; however, you should check if your driver has the recalled serial numbers before using it in surgery.
We’ve drafted a message you can send CTL Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1030-2019 — CTL Medical CTL Medical Hello, I own a CTL Medical that is covered by recall Z-1030-2019 from CTL Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
