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Recall Observatory FDA recall evidence

Device product

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

Z-1031-2019

July 05, 2018

Class II

Product summary

Firm
CTL Medical Corporation
Event
Event 82201
Status
Terminated
Classification
Class II
Quantity
133 total devices
Official record key
device-enforcement:Z-1031-2019

Official wording

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.

Code information: Lot 7EQBB-C

Distribution pattern: distributor and user level

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.