Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation…

Recall date
February 14, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0102-2018
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
OH, MI and TX

Why it was recalled

An undetected shift between the information displayed in the navigation software and the actual patient anatomy

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 Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide

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