FDA recall Z-0167-2018

Zimmer Biomet, Inc. · Class II · device

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.

Reason for recall

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

Distribution

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

Key facts

Status: Terminated
Initiation date: 2016-07-20
Report date: 2017-11-29
Termination date: 2020-06-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0167-2018