Recall of Mako RIO System Ethernet to Fiber Optic Converter

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class III
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Stryker has discovered that certain ethernet to fibre optic converters did not pass testing due to a rio connection error. a rio connection error will occur when communication is lost between the rio and the guidance module. in the event a mako system experiences a rio connection error, a network connection error message will appear on the system display.
  • Action
    Stryker will arrange replacement of all Ethernet to Fibre Optic Converters of affected units with updated converters.


  • Model / Serial
    Mako RIO System Ethernet to Fiber Optic ConverterItem Number: 200933 All lot numbers are affectedARTG Number: 223105 (Stryker Australia Pty Ltd - Robot, surgical, navigation unit)
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source