CTL Medical Corporation: Medical Device Recall in 2019 - (Recall #: Z-1031-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 5, 2018

Date Posted: March 27, 2019

Recall Number: Z-1031-2019

Event ID: 82201

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.

Status: Terminated

Product Quantity: 133 total devices

Code Information:

Lot 7EQBB-C

Distribution Pattern:

distributor and user level

Voluntary or Mandated:

Voluntary: Firm initiated