Recall Z-1030-2019 ยท MNI Orthosis, Spinal Pedicle Fixation
CTL Medical Corporation
CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
| Date | Mar 20, 2019 (initiated Jul 5, 2018) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | The anti-toggle ring of the HEX Driver, 1/4", square QC, 40 can separate form the driver shaft. |
| Quantity | 133 total devices |
| Distribution | distributor and user level |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132365 | SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION Accel Spine, Aug 20, 2013 |