# FDA recall Z-1031-2019

> **CTL Medical Corporation** · Class II · device recall initiated 2018-07-05.

## Product

CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting  Ref 019.7050

## Reason for recall

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.

## Distribution

distributor and user level

## Key facts

- **Recall number:** Z-1031-2019
- **Recalling firm:** CTL Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-05
- **Report date:** 2019-03-27
- **Termination date:** 2021-04-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Addison, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1031-2019

## Citation

> AI Analytics. FDA recall Z-1031-2019. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1031-2019. Source: US FDA. Licensed CC0.

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