Icotec Ag FDA Recalls

3 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
VADER pedicle system, torque wrench, Catalog Number 42-702Class IINov 28, 2023icotec has received notification of one revision that had to	icotec has received notification of one revision that had to be carried out because nut screws had become loos	Class IIDevices	Nov 28, 2023
VADER pedicle system, torque wrench, Catalog Number 42-703Class IINov 28, 2023icotec has received notification of one revision that had to	icotec has received notification of one revision that had to be carried out because nut screws had become loos	Class IIDevices	Nov 28, 2023
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702Class IINov 3, 2022During internal testing (at manufacturer site) of two torque	During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque l	Class IIDevices	Nov 3, 2022