FDA-Device2022-12-28Class II
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
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.
Sold states
US Nationwide distribution in the state of GA.
Affected count
6 devices
Manufactured in
Industriestrasse 12, Altstatten Sg, Switzerland
Products
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0728-2023Don't want to check this manually?
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