FDA-Device2024-01-17Class II
VADER pedicle system, torque wrench, Catalog Number 42-703
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.
Sold states
US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA
Manufactured in
Industriestrasse 12, Altstatten Sg, Switzerland
Products
VADER pedicle system, torque wrench, Catalog Number 42-703
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0701-2024Don't want to check this manually?
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