Z-1754-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2017
- Initiation Date
- February 27, 2017
- Termination Date
- August 6, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16
Product Description
MEDTECH ROSA Brain 3.0 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 neurological procedure in which the use of stereotactic surgery may be appropriate.
Reason for Recall
Unapproved change made by the supplier.
Distribution Pattern
Nationwide Distribution to CA, FL, IL, KY, MA, MN, NC, NY, OH, PA, and District of Columbia.
Code Information
Serial #'s: BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, BR16021, BR16023 and BR16025.