Events

Recall of Cortex Screw Ø 3.5 mm, self-tapping, length 28 mm, Stainless Steel

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-00948-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-08-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00948-1
  • 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
    Due to a manufacturing error, a cortex screw ø 3.5 mm, self-tapping, length 30 mm, stainless steel (part number 204.828) with an unfinished thread and malformed tip was packaged and labeled as a cortex screw ø 3.5 mm, length 28 mm, stainless steel (part number 204.028). if the presence of a screw that is 30mm instead of 28mm, with a tip that is malformed, is detected, a marginal surgical delay may arise as an alternative screw is selected. the potential for a delay increases if multiple screws of the incorrect length/malformation are present in the graphic case. if the presence is not detected, the surgeon may attempt to utilize the screw during a surgical procedure. when the surgeon attempts to insert the screw, the diameter of the non-threaded ball-like tip of the screw will not fit into the hole that is drilled. therefore insertion will not be possible.
  • Action
    Customers are asked to check their inventory immediately for the affected units and if they have any of the affected devices to immediately isolate them. This action has been closed-out on 03/02/2017.

Device

Cortex Screw Ø 3.5 mm, self-tapping, length 28 mm, Stainless Steel
  • Model / Serial
    Cortex Screw Ø 3.5 mm, self-tapping, length 28 mm, Stainless Steel Part Number: 204.828 Lot Numbers: 8573875; 8594066 ARTG Number: 157068
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd