Home / Recalls / Icotec Ag / Z-0728-2023

Z-0728-2023 Class II Ongoing

Recalled by Icotec Ag — Altstatten Sg

Recall Details

Product Type: Devices
Report Date: December 28, 2022
Initiation Date: November 3, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6 devices

Product Description

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 Pattern

US Nationwide distribution in the state of GA.

Code Information

UDI/DI: (01) 07640164844589, Serial Numbers: 200221-040, 200221-041, 200221-042, 200221-043, 200221-044, 200221-045