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.
Reported: November 29, 2017 Initiated: July 20, 2016 #Z-0167-2018
Product Description
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.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 18 (14 US and 4 OUS)
- Distribution
- Worldwide Distribution - US Nationwide in the states of OH, FL, MA, MN, DC, NC, CA, NY, PA and countries of Australia and France
- Location
- Warsaw, IN
Frequently Asked Questions
What product 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.. Recalled by Zimmer Biomet, Inc.. Units affected: 18 (14 US and 4 OUS).
Why was this product recalled? ▼
Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 29, 2017. Severity: Moderate. Recall number: Z-0167-2018.
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