Z-0167-2018 Class II Terminated
FDA device recall Z-0167-2018 was initiated by Zimmer Biomet, Inc. on Jul 20, 2016 and is designated Class II. Reason for recall: Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller. The recall status is terminated (terminated Jun 16, 2020). Affected quantity: 18 (14 US and 4 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Nov 29, 2017
- Initiation Date
- Jul 20, 2016
- Termination Date
- Jun 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 (14 US and 4 OUS)
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.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of OH, FL, MA, MN, DC, NC, CA, NY, PA and countries of Australia and France
Code Information
Serial #'s: BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, and BR16021
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0167-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026