Recall Z-1031-2019
CTL Medical Corporation · initiated July 5, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
Codes / lots: Lot 7EQBB-C
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
The anti-toggle ring of the HEX Driver, 1/4", square QC, 40 can separate form the driver shaft.
Details
- Recall number
- Z-1031-2019
- Initiated
- July 5, 2018
- Posted by FDA
- March 20, 2019
- Terminated
- April 28, 2021
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Quantity
- 133 total devices
- Distribution
- distributor and user level
- Recalling firm
- CTL Medical Corporation, Addison, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1030-2019 Class II | CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery… | 07/05/2018Terminated |