CTL Medical recalls 1/4" Square QC Hex Drivers with serial number 7EQBB-C due to risk of anti-toggle ring separating during surgery, potentially causing screw failure. Affected units may need repair or replacement.
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 certain hex drivers used in surgery because the anti-toggle ring might separate during use. This could cause screws to become loose or fail, risking complications in spinal surgery. Affected units have a specific serial number.
The anti-toggle ring can detach from the driver shaft during surgery. If it remains in the screw head, it may interfere with proper tightening, causing the screw to become loose or fail. This could lead to instability in the spinal construct.
Surgical teams using the recalled hex drivers for spinal procedures are most at risk. Patients undergoing spinal surgery with these devices may face complications if the anti-toggle ring separates.
Check for the model 'CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting' with serial number 7EQBB-C. The product was sold under the manufacturer's name CTL Medical Corporation.
Look for the serial number 7EQBB-C on the product.
The recall states the anti-toggle ring may separate during surgery, so it is not safe for use without the fix.
The recall does not specify a remedy, so contact CTL Medical Corporation directly for guidance.
The recall mentions risk of screw failure in spinal surgery, which could lead to complications, but does not specify injury details.
We’ve drafted a message you can send CTL Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1031-2019 — CTL Medical CTL Medical Hello, I own a CTL Medical that is covered by recall Z-1031-2019 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.
