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Terminated

CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050

FDA Recall Z-1030-2019 · Posted 2019-03-20

Recalling FirmCTL Medical Corporation
Recall StatusTerminated
Product CodeMNI
Date Initiated2018-07-05
Date Terminated2021-04-28
Product Quantity133 total devices

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.

Firm Action

The anti-toggle ring of the HEX Driver, 1/4", square QC, 40 can separate form the driver shaft.

Root Cause

Nonconforming Material/Component

Distribution Pattern

distributor and user level

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K132365SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATIONAccel Spine · 2013-08-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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