Events

Recall of Prosthesis, internal, spine, disc(The prosthesis is intended as an adjunct to a lumbar discectomy procedure as a means to maintain the relative position of nucleus within the disc space, thereby reducing the risk of a recurrent herniation.)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Global Orthopaedic Technology 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-2015-RN-00002-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-02-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00002-1
  • 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
    Intrinsic therapeutics inc has identified a manufacturing defect affecting a select number of batches of the delivery tool (instrument). the defect can cause the instrument to break under stress during surgery. this defect does not impact the implant, its performance or possible safety of patients.
  • Action
    1. Quarantined all stock on hand in the Global Orthopaedic Technology warehouse; 2. All Stock Recalled and physically had returned to Global Orthopaedic Technology warehouse that was on consignment with 1 hospital and on loan with second hospital. 3. All product recalled, quarantined and returned to the manufacturer. This action was undertaken prior to consultation with the Therapeutic Goods Administration.

Device

Prosthesis, internal, spine, disc(The prosthesis is intended as an adjunct to a lumbar discectomy...
  • Model / Serial
    Prosthesis, internal, spine, disc(The prosthesis is intended as an adjunct to a lumbar discectomy procedure as a means to maintain the relative position of nucleus within the disc space, thereby reducing the risk of a recurrent herniation.)ARTG Number: 182175
  • Manufacturer
    Global Orthopaedic Technology Pty Ltd

Manufacturer

Global Orthopaedic Technology Pty Ltd