Recall of Proximate PPH Hemorrhoidal Circular Stapler and Accessories 33mm, Product code PPH03 and Proximate HCS Hemorrhoidal Circular Stapler and Accessories 33mm, Product code PPH01 (Used for treatment of prolapse and hemorrhoids)

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-2012-RN-00798-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-06
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • 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
    There is difficulty firing the device which may result in an incomplete firing stroke that may result in incomplete staple formation.
  • Action
    Quarantine and return affected product to Johnson & Johnson Medical

Device

  • Model / Serial
    Proximate PPH Hemorrhoidal Circular Stapler and Accessories 33mm, Product code PPH03 and Proximate HCS Hemorrhoidal Circular Stapler and Accessories 33mm, Product code PPH01 (Used for treatment of prolapse and hemorrhoids)All lot numbers affectedARTG Number: 99218
  • Manufacturer

Manufacturer