FDA Device recall Z-1030-2019
CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
- FDA Device
- Class II
- terminated
- Published 2019-03-27
On 2019-03-27 the FDA classified a Class II recall of CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050 by Ctl Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1030-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-05 |
| Published | 2019-03-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ctl Medical |
| Distribution | n/a |
Product
CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
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.
Identifiers
| code_info | Lot 7EQAB-D, 7ATAB-D |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1030-2019%22
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