Recall Z-1030-2019— CTL Medical Corporation

Name: FDA recall Z-1030-2019
Creator: U.S. Food and Drug Administration
Published: 2018-07-05

Class II · Terminated

Class II FDA medical device recall by CTL Medical Corporation, initiated 2018-07-05, terminated 2021-04-28. It names one FDA 510(k) clearance: K132365. Product: CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050. 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..

Recalling firm: CTL Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-07-05
Terminated: 2021-04-28
Firm location: Addison, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K132365 — SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATIONAccel Spine·cleared 2013-08-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.