Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls ROSA BRAIN 3.0.0

Recall date
July 29, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0116-2018
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
OH and PA.

Why it was recalled

Non-conforming product label.

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 3.0.0

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