Zimmer Biomet, Inc. recalls ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or too…

Recall date

July 20, 2016

Source

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

Recall number

Z-0167-2018

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide in the states of OH, FL, MA, MN, DC, NC, CA, NY, PA and countries of Australia and France

Why it was recalled

Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller.

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

What was recalled

ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.