Events

Recall of Guide Wire diameter 3.2mm, length 400mm (Fixation nail guidewire)

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-00611-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-06-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00611-1
  • 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
    The packaging for the selected part and lot numbers of the guide wire ø 3.2 mm, length 400 mm were mislabelled with an incorrect material. the label incorrectly declares 'molybdenum' instead of wolfram and nickel as alloyed elements. the correct label should indicate “cocrwni alloy”. during the normal course of the surgery, the risk of adverse tissue reaction is decreased as the guide wire is not retained in the body after the procedure is completed. in the case of a broken guide wire, a fragment may be retained after surgery. in this case, a patient with sensitivity to nickel could develop a moderate adverse tissue reaction.
  • Action
    Customers are advised to immediately isolate the affected stock for returning to Synthes Australia.

Device

Guide Wire diameter 3.2mm, length 400mm (Fixation nail guidewire)
  • Model / Serial
    Guide Wire diameter 3.2mm, length 400mm (Fixation nail guidewire)Part Number: 357.399Lot Numbers: 7560756, 7584396, 7594896, 7560829, 7562800, 7589236, 7594058, 7583667, 7589696 and 7594057 ARTG Number: 203637
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd