FDA Device

ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.

Hazard

Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.

What You Should Do

Remedy

Zimmer Biomet Field Service Technicians replaced Field Locking Systems on site.

Products

ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicate
Brand
Zimmer Biomet, Inc.
UPC
Serial No. BR16004, BR15002, and BR15003

Units Affected

3 units