FDA Device

ROSA BRAIN 3.0.0

Hazard

Non-conforming product label.

What You Should Do

Remedy

All affected devices received a corrected label. Correction notification and implementation were performed by field technicians.

Products

ROSA BRAIN 3.0.0
Brand
Zimmer Biomet, Inc.
UPC
Serial No. BR16017 and BR16018

Units Affected

2 devices