Medical device recalls Moderate risk

Mako Surgical Corporation recalls Robotic Arm Interactive Orthopedic System (RIO)

Recall date
April 30, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1508-2016
FDA classification
Class II
Brand / firm
Mako Surgical Corporation
Sold / distributed
Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Italy, Japan, Hong Kong, Scotland, Germany, Turkey , Greece, Singapore, Taiwan and South Korea.

Why it was recalled

Revision of the field manual

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

What was recalled

Robotic Arm Interactive Orthopedic System (RIO)

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