Events

Recall of Visionaire Lightweight Alignment Rod

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smith & Nephew 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-2018-RN-00742-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-06-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00742-1
  • 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
    Smith & nephew have identified that the product visionaire lightweight alignment rod is oversized, preventing mating with the visionaire alignment connector.
  • Action
    Once the recall acknowledgement has been received and there is product to be retrieved, a Smith & Nephew Representative will go to the hospital to retrieve the affected items are provide replacement products

Device

Visionaire Lightweight Alignment Rod
  • Model / Serial
    Visionaire Lightweight Alignment RodModel Number: 71440302 Batch Number: 17HCL0004E ARTG Number: 150435(Smith & Nephew - Orthopaedic prosthesis implantation instrument)
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd