Events

Recall of Glenosphere Orientation Guide Instrument used with the Delta EXTEND Reverse Shoulder System.

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 Australia.

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-00552-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-05-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00552-1
  • 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
    Johnson and johnson has identified that the arrow used for eccentric glenosphere orientation is etched on the wrong side of the glenosphere guide instrument. using the wrong side of the guide instrument could result in the misalignment of the eccentric glenosphere with the superior and proximal portion of the shoulder blade.
  • Action
    Surgeons are being advised of the clinical implications of incorrect implant orientation, including the potential for revision surgery. JJM does not recommend the prophylactic revision in the absence of symptoms. For more details, please see http://www.tga.gov.au/safety/alerts-device-glenosphere-orientation-guide-130607.htm .

Device

Glenosphere Orientation Guide Instrument used with the Delta EXTEND Reverse Shoulder System.

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia