# FDA recall Z-0609-2019

> **Mazor Robotics Ltd** · Class II · device recall initiated 2014-11-26.

## Product

Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038).  Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.

## Reason for recall

In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.

## Distribution

Affected devices were distributed in the US to four different medical facilities in four states

## Key facts

- **Recall number:** Z-0609-2019
- **Recalling firm:** Mazor Robotics Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2014-11-26
- **Report date:** 2018-12-26
- **Termination date:** 2019-07-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Industrial Park, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0609-2019

## Citation

> AI Analytics. FDA recall Z-0609-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0609-2019. Source: US FDA. Licensed CC0.

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