Z-0728-2023 Class II Terminated
FDA device recall Z-0728-2023 was initiated by Icotec Ag on November 3, 2022 and is designated Class II. 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. T… The recall status is terminated (terminated September 10, 2026). Affected quantity: 6 devices.
Recall Details
- Product Type
- Devices
- Report Date
- December 28, 2022
- Initiation Date
- November 3, 2022
- Termination Date
- September 10, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 devices
Product Description
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
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.
Distribution Pattern
US Nationwide distribution in the state of GA.
Code Information
UDI/DI: (01) 07640164844589, Serial Numbers: 200221-040, 200221-041, 200221-042, 200221-043, 200221-044, 200221-045