CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
FDA device recall Z-1031-2019 · posted 2019-03-20 · Terminated
Recall details
- Recalling firm
- CTL Medical Corporation
- 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.
- Action taken
- The anti-toggle ring of the HEX Driver, 1/4", square QC, 40 can separate form the driver shaft.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 133 total devices
- Distribution
- distributor and user level
- Date initiated
- 2018-07-05
- Date posted
- 2019-03-20
- Date terminated
- 2021-04-28
- Location
- Addison, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION (K132365) | Accel Spine | 2013-08-20 |