Icotec Ag Recalls
3 recalls on record · December 28, 2022 to January 17, 2024 · Medical Devices
Recalls by year
22
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 17, 2024Medical DevicesFDA
Icotec Ag recalls VADER pedicle system, torque wrench, Catalog Number 42-703
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.
January 17, 2024Medical DevicesFDA
Icotec Ag recalls VADER pedicle system, torque wrench, Catalog Number 42-702
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.
December 28, 2022Medical DevicesFDA
Icotec Ag recalls VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
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.