FDA recall Z-0701-2024

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2023-11-28

Report date

2024-01-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Altstatten Sg, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0701-2024