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Icotec Ag recalls VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Recalled December 28, 2022 · FDA recall Z-0728-2023 · Icotec Ag
Hazard
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 Class II
Units
6 devices
Sold at
US Nationwide distribution in the state of GA.
Description
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.
Product
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Manufacturer(s)
Icotec Ag
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →