FDANovember 3, 2022device
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
icotec agicotec
UPCs
07640164844589
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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