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

Recall date

November 3, 2022

Source

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

Recall number

Z-0728-2023

FDA classification

Class II

Brand / firm

Icotec Ag

Sold / distributed

US Nationwide distribution in the state of GA.

Why it was recalled

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.

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, Hudson Coupling, 12 Nm, REF 42-702