FDA Medical Device Recalls (openFDA)
CTL Medical Corporation: CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
- Recall number
- Z-1031-2019
- Recalling firm
- CTL Medical Corporation
- Product
- CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
- Status
- Terminated
- Initiated
- 2018-07-05
- Posted
- 2019-03-20
- Terminated
- 2021-04-28
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- The anti-toggle ring of the HEX Driver, 1/4", square QC, 40 can separate form the driver shaft.
- Quantity
- 133 total devices
- Distribution
- distributor and user level
- Lot, serial or model codes
- Lot 7EQBB-C
- 510(k) numbers
- ["K132365"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 3009051471
- Firm city
- Addison
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28