Icotec Ag: Medical Device Recall in 2022 - (Recall #: Z-0728-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 3, 2022

Date Posted: December 28, 2022

Recall Number: Z-0728-2023

Event ID: 91174

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.

Status: Ongoing

Product Quantity: 6 devices

Code Information:

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

Distribution Pattern:

US Nationwide distribution in the state of GA.

Voluntary or Mandated:

Voluntary: Firm initiated