Events

Recall of Guide Wire Ø 3.2 mm, length 400 mm (used for the implantation of intramedullary nails)

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-00371-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-03-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00371-1
  • 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 wrong material (stainless steel) is indicated on the product label. the product is made of cobalt chrome. there is a potential harm associated with the mislabelled product for adverse tissue reaction especially if the guidewire breaks during surgery and a fragment is retained.
  • Action
    Synthes is notifying their customers of the incorrect information on the product labels and is providing additional safety advice to mitigate the risk of cobalt sensitivity reactions.

Device

Guide Wire Ø 3.2 mm, length 400 mm (used for the implantation of intramedullary nails)
  • Model / Serial
    Guide Wire Ø 3.2 mm, length 400 mm (used for the implantation of intramedullary nails)Part number: 357.399Lot Numbers: All lot numbers prior to 7527384 ARTG Number: 203637
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd