FDANovember 28, 2023device
VADER pedicle system, torque wrench, Catalog Number 42-702
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly. Due to the malfunction, the nut screws may not have been tightened sufficiently.
What to do
FDA enforcement status: Ongoing
Brands named
icotec agicotec
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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