FDA recall Z-1030-2019

CTL Medical Corporation · Class II · device

Product

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.

Distribution

distributor and user level

Key facts

Status
Terminated
Initiation date
2018-07-05
Report date
2019-03-27
Termination date
2021-04-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Addison, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1030-2019