# FDA recall Z-1761-2025

> **Augmedics Ltd.** · Class II · device recall initiated 2025-04-14.

## Product

Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery.

## Reason for recall

The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** Z-1761-2025
- **Recalling firm:** Augmedics Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-14
- **Report date:** 2025-05-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Yokneam Illit Northern, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1761-2025

## Citation

> AI Analytics. FDA recall Z-1761-2025. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1761-2025. Source: US FDA. Licensed CC0.

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