Mazor Robotics Ltd recalls Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868

Recall date

July 2, 2019

Source

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

Recall number

Z-0721-2020

FDA classification

Class II

Brand / firm

Mazor Robotics Ltd

Sold / distributed

US: Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, New York, North Carolina, North Dakota, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia

Why it was recalled

The firm has become aware that the Snapshot Trackers were not manufactured in accordance with specifications and could potentially lead to navigational inaccuracies, which may result in patient injury, e.g. nerve damage or neurological deficit/dysfunction

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

What was recalled

Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868