Z-1031-2019Class II

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

Name: Z-1031-2019 CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
Creator: CTL Medical Corporation
Published: 2018-07-05
License: https://open.fda.gov/license/

CTL Medical Corporation / initiated 2018-07-05 / Terminated / root cause: manufacturing process

FDA source

CTL Medical Corporation began a recall of CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050 on 2018-07-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1031-2019
Classification: Class II
Status: Terminated
Initiated: 2018-07-05
Posted: 2019-03-20
Terminated: 2021-04-28
Recalling firm: CTL Medical Corporation
Product: CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 133 total devices
Distribution: distributor and user level
Product codes and lots: Lot 7EQBB-C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1031-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1030-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-27	2019-03-20
Z-1031-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-27	2019-03-20

Product code NKB

K132365Class IISpondylolisthesis Spinal Fixation, Spinal Pedicle FixationAccel Spine / cleared 2013-08-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)