Events

Recall of Cortex Screw Ø 4.5mm, self-tapping, length 20mm, Pure Titanium

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

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-00570-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00570-1
  • 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 affected part and lot numbers of the 4.5mm cortex screws, length 20mm, may contain a 4.5mm cortex screw that is 22mm in length; the screws are both etched and labelled with the affected 20mm part numbers.The outside package labelling and the etching on the product would indicate to the user that the screw is 2mm shorter than its actual length of 22mm. if detected prior to insertion it may result in a surgical delay while a replacement is obtained or if the surgeon inserts the screw, determines it was the wrong length on radiographic imaging, and then removes and replaces it.In addition, the potential harm of damage to surrounding structures including damage to articular surface during insertion could occur, depending upon the location and angle of screw. a screw that is too long can also result in soft tissue damage (soft tissue irritation) if not recognised during the procedure. at this time there have been no reports of patient involvement.
  • Action
    JJM is advising users to inspect stock and quarantine the affected units prior to their return to JJM. Past surgical results should be reviewed at the discretion of the surgeon for patients who have been implanted with screws from this particular lot number. This action has been closed out on 19/01/2017.

Device

Cortex Screw Ø 4.5mm, self-tapping, length 20mm, Pure Titanium

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes