Recall Z-0728-2023 · NKB Thoracolumbosacral Pedicle Screw System
Icotec Ag
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
| Date | Dec 19, 2022 (initiated Nov 3, 2022) |
| Status | Terminated |
| Reason | During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring results for both instruments were 4 Nm. |
| Root cause | Nonconforming Material/Component |
| Action | Icotec issued a Field Action Notice to its consignee on 11/03/2022 by email. The notice explained the issue and that XXXX. The firm followed with an email to inform the consignee of their intent to recall the device. The notice requested the return of the device from the field. The firm will be replacing the devices. |
| Quantity | 6 devices |
| Distribution | US Nationwide distribution in the state of GA. |
| FDA record | Open on fda.gov |