Recall Z-0728-2023
Icotec Ag · initiated November 3, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Codes / lots: UDI/DI: (01) 07640164844589, Serial Numbers: 200221-040, 200221-041, 200221-042, 200221-043, 200221-044, 200221-045
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0728-2023
- Initiated
- November 3, 2022
- Posted by FDA
- December 19, 2022
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Quantity
- 6 devices
- Distribution
- US Nationwide distribution in the state of GA.
- Recalling firm
- Icotec Ag, Altstatten Sg