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-0639-2018

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