Robotic Arm Interactive Orthopedic System recall
Robotic Arm Interactive Orthopedic System (RIO)
Why was Robotic Arm Interactive Orthopedic System recalled?
Revision of the field manual
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog # 203900 & 207092 All lots
- Product
- Robotic Arm Interactive Orthopedic System (RIO)
- Recalling firm
- Mako Surgical Corporation
- Quantity
- 249
- Distribution
- Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Italy, Japan, Hong Kong, Scotland, Germany, Turkey , Greece, Singapore, Taiwan and South Korea.
- Recall date
- April 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)