Icotec Ag recalls VADER pedicle system, torque wrench, Catalog Number 42-703

Recall date

November 28, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0701-2024

FDA classification

Class II

Brand / firm

Icotec Ag

Sold / distributed

US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VADER pedicle system, torque wrench, Catalog Number 42-703