Events

Recall of Sterile K-Wire and Steinmann Pin Products (Typically used for temporary fixation of bones in the extremities)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smith & Nephew Surgical 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-2013-RN-00897-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-08-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00897-1
  • 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
    Sterile k-wire and steinmann pin products are being recalled due to a packaging issue. specifically, there is a concern with the inner sterile pouch sealing of the product that may constitute a breach of the sterile barrier.
  • Action
    Smith & Nephew is advising users to inspect stock for affected product. Any affected product will be replaced by Smith & Nephew.

Device

Sterile K-Wire and Steinmann Pin Products (Typically used for temporary fixation of bones in the ...
  • Model / Serial
    Sterile K-Wire and Steinmann Pin Products (Typically used for temporary fixation of bones in the extremities)Multiple part and lot numbers affectedARTG number: 131082
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd