Class II — Potential Health Hazard

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

Carousel MAS1025-01 Recalled by Mazor Robotics Ltd Due to In some situations the carousel position pin (locker)...

Date: November 26, 2014
Company: Mazor Robotics Ltd
Status: Terminated
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 Mazor Robotics Ltd directly.

Affected Products

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.

Quantity: 5 units

Why Was This Recalled?

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

Where Was This Sold?

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

About Mazor Robotics Ltd

Mazor Robotics Ltd has 5 total recalls tracked by RecallDetector.

Related Recalls

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