Events

Recall of Cortex Screw Ø 1.5 mm, self-tapping, length 8 mm (non-biodegradeable orthopaedic 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-2014-RN-00646-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-06-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00646-1
  • 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 packaging for item 400.688s (cortex screw ø 1.3 mm, self-tapping, length 8 mm, sterile) was found to contain product 400.808s (cortex screw ø 1.5 mm, self-tapping, length 8 mm, sterile). the presence of a screw that is 1.5mm in diameter instead of 1.3mm (or 1.3mm vs 1.5mm) may cause surgical delay if the surgeon may specifically require a 1.3 or 1.5mm due to the patient's impacted anatomical structure.
  • Action
    Customers are requested to isolate Cortex Screw Ø 1.5 mm, self-tapping, length 8 mm from the affected lot for return to DePuy Synthes.

Device

Cortex Screw Ø 1.5 mm, self-tapping, length 8 mm (non-biodegradeable orthopaedic bone screw)
  • Model / Serial
    Cortex Screw Ø 1.5 mm, self-tapping, length 8 mm (non-biodegradeable orthopaedic bone screw)Part Number: 400.808 Lot Number: 2798707 ARTG Number: 157068
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd