Z-1031-2019 Class II Terminated
FDA device recall Z-1031-2019 was initiated by CTL Medical Corporation on July 5, 2018 and is designated Class II. 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 sc… The recall status is terminated (terminated April 28, 2021). Affected quantity: 133 total devices.
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2019
- Initiation Date
- July 5, 2018
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 133 total devices
Product Description
CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
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 Pattern
distributor and user level
Code Information
Lot 7EQBB-C