CTL Medical Hex Driver — Class II medical device recall Z-1030-2019
Terminated recall by CTL Medical Corporation, reported 2019-03-27. the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the
| Recall number | Z-1030-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CTL Medical Corporation, Addison, TX, United States |
| Recall initiated | 2018-07-05 |
| Classified | 2019-03-20 |
| Reported by FDA | 2019-03-27 |
| Terminated | 2021-04-28 |
| Quantity | 133 devices |
| Lot numbers | 7ATAB-D, 7EQAB-D |
| Model numbers | 015.7050 |
Product
CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1030-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.