Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 27, 2019
CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
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…
Ctl Medical Corporation recalled CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050 - a moderate-severity action.
CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050 was recalled by Ctl Medical Corporation in March 27, 2019. Reason: the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the…. Check the official notice for the remedy. Verify recall #Z-1031-2019 with the FDA Devices before acting.
The recall
Ctl Medical Corporation issued this moderate-severity FDA Devices recall-the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the….
- Moderate
- severity level
- Class II
- classification
- March 27, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1031-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1031-2019) was formally reported on March 27, 2019, with the manufacturer initiating the action on July 5, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Ctl Medical Corporation is listed as the recalling firm, operating out of Addison, TX. Federal records list the affected scope as 133 total devices.
The documented reason for this recall is: 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 housin… Distribution data in the federal record shows the product reached: distributor and user level. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
133 total devices
Related Recalls
6
6 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1031-2019 |
| Date reported | March 27, 2019 |
| Date initiated | July 5, 2018 |
| Recalling firm | Ctl Medical Corporation |
| Firm location | Addison, TX |
| Affected scope | 133 total devices |
| Distribution | distributor and user level |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1031-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050. Recalled by Ctl Medical Corporation. Units affected: 133 total devices.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 27, 2019. Severity: Moderate. Recall number: Z-1031-2019.
Where was the recalled product distributed? ▼
Distribution: distributor and user level.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1031-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 27, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.