# FDA recall Z-0700-2024

> **Icotec Ag** · Class II · device recall initiated 2023-11-28.

## Product

VADER pedicle system, torque wrench, Catalog Number 42-702

## Reason for recall

icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly. Due to the malfunction, the nut screws may not have been tightened sufficiently.

## Distribution

US:  AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA

## Key facts

- **Recall number:** Z-0700-2024
- **Recalling firm:** Icotec Ag
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-28
- **Report date:** 2024-01-17

- **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-0700-2024

## Citation

> AI Analytics. FDA recall Z-0700-2024. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0700-2024. Source: US FDA. Licensed CC0.

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