Recall of MIA16 Minimally Invasive Attachment used with the Anspach Product Insert version 18-0074 Rev A 05/12

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Synthes 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 II
  • 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
    During hydrogen peroxide sterilisation testing of the mia16 device it was determined that the sterrad 100s is not capable of achieving the expected sterility assurance level (sal) of 10^-6. therefore, sterrad 100s should not be used for sterilising the mia16 attachment.
  • Action
    End users are advised to not use the Sterrad 100S to sterilise the MIA16 attachment.


  • Model / Serial
    MIA16 Minimally Invasive Attachment used with the AnspachProduct Insert version 18-0074 Rev A 05/12ARTG Number: 141597
  • Manufacturer