FDA recall Z-0728-2023

Product

VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702

Reason for recall

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.

Distribution

US Nationwide distribution in the state of GA.

Key facts

Status

Ongoing

Initiation date

2022-11-03

Report date

2022-12-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Altstatten Sg, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0728-2023