# FDA recall Z-0728-2023

> **Icotec Ag** · Class II · device recall initiated 2022-11-03.

## 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

- **Recall number:** Z-0728-2023
- **Recalling firm:** Icotec Ag
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-03
- **Report date:** 2022-12-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Altstatten Sg, Switzerland

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0728-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0728-2023. Source: US FDA. Licensed CC0.

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