Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orien…

Recall date
May 1, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0638-2018
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA.

Why it was recalled

Robot arm being sent to the wrong position

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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