VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702

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.

Code information: UDI/DI: (01) 07640164844589, Serial Numbers: 200221-040, 200221-041, 200221-042, 200221-043, 200221-044, 200221-045

Distribution pattern: US Nationwide distribution in the state of GA.