ROSA Brain, 3.0.0 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 neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
Hazard
Complaint of the head holder connector locking up mechanically when tightened.
What You Should Do
Remedy
Product was/will be corrected by Field Technician staff in the form of a visit.
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Products
ROSA Brain, 3.0.0
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 (biops
- Brand
- Zimmer Biomet, Inc.
- UPC
- Device Listing No. D264591, Serial No. BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, BR16021, BR16023, BR16024.
Units Affected
20 units (16 US, 4 OUS)