Events

Recall of Straight Adjustable Gastric Band Product Code: 2200X & BD2XV

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical 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-2013-RN-01030-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01030-1
  • 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 manufacturer ethicon endo-surgery, has determined that the straight adjustable gastric band was unable to pass the internal test for 'force to close'. as a result surgeons may experience difficulty in locking the straight gastric band buckle during implantation. once the product is locked, the gastric band will remain in place and will function as intended.
  • Action
    JJM is requesting customers to return affected product for a credit note. The Straight Adjustable Gastric Band will not be available in the market in the future.

Device

Straight Adjustable Gastric Band Product Code: 2200X & BD2XV
  • Model / Serial
    Straight Adjustable Gastric Band Product Code: 2200X & BD2XVAll lot numbers affectedARTG Number: 94766
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd