Events

Recall of Cortex Screw 3.5mm, self-tapping, length 60mm, Stainless Steel, sterile (Orthopaedic non-biodegradable bone screw)

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-2013-RN-00424-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-05-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00424-1
  • 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 length of the screw is erroneously indicated as 55mm in the six languages on the back of the box. in the english short text which is visible on the front of the box, on the sides, on the sterile inner blister and on the patient labels, the screw is correctly described as having a length of 60mm.
  • Action
    Synthes is recalling affected units and replacing it with unaffected lots.

Device

Cortex Screw 3.5mm, self-tapping, length 60mm, Stainless Steel, sterile (Orthopaedic non-biodegra...
  • Model / Serial
    Cortex Screw 3.5mm, self-tapping, length 60mm, Stainless Steel, sterile (Orthopaedic non-biodegradable bone screw)Part number: 204.860SMultiple lot numbers affectedARTG Number: 157068
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd