Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

VADER Pedicle System Torque Wrench Recalled by Icotec Ag Due to During internal testing (at manufacturer site) of two...

Date: November 3, 2022
Company: Icotec Ag
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Icotec Ag directly.

Affected Products

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

Quantity: 6 devices

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Icotec Ag

Icotec Ag has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report