Icotec Ag
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Icotec Ag and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-01-17FDA-DeviceClass IIVADER pedicle system, torque wrench, Catalog Number 42-703
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.
- 2024-01-17FDA-DeviceClass IIVADER pedicle system, torque wrench, Catalog Number 42-702
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.
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