FDA-Device2018-02-28Class II
ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
Zimmer Biomet, Inc.
Hazard
Robot arm being sent to the wrong position
Sold states
Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA.
Affected count
16
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0638-2018Don't want to check this manually?
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