FDAClass IISeptember 26, 2018

Makoplasty RIO Standard System recall

Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the…

Why was Makoplasty RIO Standard System recalled?

Communication-connection error.

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?

ALL LOTS

Product
Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the…
Recalling firm
Mako Surgical Corporation
Quantity
736 (US) and 174 (OUS)
Distribution
Worldwide Distribution - US Nationwide and the countries of Australia, New Zealand, Taiwan, China, Hong Kong, Greece, United Kingdom, England, Netherlands, Luxembourg, Germany, Ireland, Switzerland, Italy, India, Japan, South Korea, Vietnam, South Africa, and Turkey,
Recall date
September 26, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls