Medical Device Recall: VADER pedicle system, torque wrench, Catalog Number 42-702
Icotec Ag · November 28, 2023
Reason for Recall
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.
Distribution
US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA
States Affected
AZ, CA, CO, DE, MI, NC, NY, OH, PA, TX
Quantity Affected
79 devices (US only)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0700-2024
Status: ongoing
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