FDA-Device2018-02-28Class II
ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.
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
1
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0639-2018Don't want to check this manually?
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