Events

Recall of Distraction Screws Packaged sterile(Orthopaedic bone screw)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by CareFusion Australia 316 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-2016-RN-01575-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01575-1
  • 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
    Between 1 july 2011 and 30 june 2016, the manufacturer has received 14 reports from customers in the usa of corrosion being evident on screws as they are removed from the immediate packaging. in australia, no reports of this issue have been received by bd. while no cases have been reported, degradation products of metal corrosion can result in inflammatory response locally and/or systemically. the elderly, pregnant, critically ill and immune-compromised patients may, however, be at greater risk if failure were to occur.
  • Action
    Customers are advised to immediately quarantine any remaining stock. They will be contacted to arrange return of the quarantined stock.

Device

Distraction Screws Packaged sterile(Orthopaedic bone screw)
  • Model / Serial
    Distraction Screws Packaged sterile(Orthopaedic bone screw)Models: S-0088, S-0089, S-0090 & S-0091All lot numbers that are still within their labelled 5 shelf life ARTG Number: 263050
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd