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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