Events

Recall of Proceed Surgical MeshProduct Code PCDT1

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-2014-RN-00189-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-02-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00189-1
  • 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 possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination. delamination is a separation of the two layers that compose the product.
  • Action
    Customers are requested to quarantine the affected device prior to returning to JJM.

Device

Proceed Surgical MeshProduct Code PCDT1

Manufacturer

Johnson & Johnson Medical Pty Ltd