Recall of Hand Switch for Electric Pen Drive (electrical drive for use with a range of surgical attachments)

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
    The hand switch attachment has been incorrectly labelled. the position of the "on" and "lock" labels are reversed on some units.
  • Action
    Synthes Australia is requesting customers to inspect their stock and isolate any incorrectly labelled devices. Affected devices are to be returned to Synthes Australia. A replacement unit will be provided.


  • Model / Serial
    Hand Switch for Electric Pen Drive (electrical drive for use with a range of surgical attachments)Part Number: 05.001.012Lot Numbers: AV19044; AV18166; and AV20666ARTG Number: 157072
  • Manufacturer