Mazor Robotics Ltd recalls Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Rena…

Recall date

November 26, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0609-2019

FDA classification

Class II

Brand / firm

Mazor Robotics Ltd

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.