CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref… recallZ-1030-2019 · CTL Medical Corporation · initiated Jul 5, 2018
Class II Terminated All recalls posted in March 2019
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CTL Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
The anti-toggle ring of the HEX Driver, 1/4", square QC, 40 can separate form the driver shaft.
Recall details
- Recall number
- Z-1030-2019
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 5, 2018
- Posted by the FDA
- Mar 20, 2019
- Recalling firm
- CTL Medical Corporation
- Quantity
- 133 total devices
- Product code
- MNI
- FDA submissions
- K132365
- Distribution
- distributor and user level
Product description
CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
Code information (models, lots, serial numbers)
Lot 7EQAB-D, 7ATAB-D
Other devices under the same FDA submission
1 device cleared under K132365 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- RAPHAEL Pedicle Screw System 015.3237CTL Medical Corporation · ORTHOSIS, SPINAL PEDICLE FIXATION1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 82201).
- Z-1031-2019 · TerminatedCTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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