Home / Recalls / Medical Devices
Icotec Ag recalls VADER pedicle system, torque wrench, Catalog Number 42-703
Recalled January 17, 2024 · FDA recall Z-0701-2024 · Icotec Ag
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. · FDA Class II
Sold at
US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA
Description
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.
Product
VADER pedicle system, torque wrench, Catalog Number 42-703
Manufacturer(s)
Icotec Ag
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →