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Zimmer Biomet, Inc. recalls ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or
Recalled November 29, 2017 · FDA recall Z-0167-2018 · Zimmer Biomet
Hazard
Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller. · FDA Class II
Units
18 (14 US and 4 OUS)
Sold at
Worldwide Distribution - US Nationwide in the states of OH, FL, MA, MN, DC, NC, CA, NY, PA and countries of Australia and France
Description
Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller.
Product
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.
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →