Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls ROSA Surgical Device 2.5.8

Recall date
April 8, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0115-2018
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, MO, NY, OH, PA, TX, and WA Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain, and United Kingdom

Why it was recalled

Potential for software to change the final tool orientation for the command position without command.

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

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