Events

Recall of Anspach Attachments and Handpieces (reusable surgical devices)

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
    Recall
  • Event ID
    RC-2014-RN-00651-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-06-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00651-1
  • 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
    Internal testing of sterrad® 100s sterilisation process has shown that several anspach attachments and handpieces did not achieve the expected sterility assurance level (sal) of 10-6.
  • Action
    Synthes Australia is notifying their customers of the removal of the recommendation to sterilise Anspach Attachments and Handpieces in the STERRAD 100S (Hydrogen Peroxide Gas Plasma Technology). Steam sterilisation method is still validated for the sterilisation of these devices.

Device

Anspach Attachments and Handpieces (reusable surgical devices)
  • Model / Serial
    Anspach Attachments and Handpieces (reusable surgical devices)Multiple part numbers and lot numbersARTG Numbers: 141597, 141559, 141600, 146267 and 155913
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd