Events

Recall of GYNEMESH PS and TVT DevicesGynemesh PS

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-2015-RN-00743-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-09-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00743-1
  • 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 & johnson medical pty. ltd. (jjm) is issuing a notification to inform hospitals and surgeons of changes to the instructions for use (ifu) for ethicon gynemesh ps and tvt devices.The changes include additional information on adverse reactions, warnings, precautions and patient selection.
  • Action
    Johnson & Johnson Medical (JJM) is issuing a notification to inform hospitals and healthcare professionals of changes to the Instructions for Use (IFU) for Ethicon GYNEMESH PS and TVT Devices. These changes have been made following the TGA’s clinical review of urogynaecological meshes and include additional information on include additional information on adverse events, warnings and contra-indications. This action has been closed-out on 22/08/2016.

Device

GYNEMESH PS and TVT DevicesGynemesh PS
  • Model / Serial
    GYNEMESH PS and TVT DevicesGynemesh PSProduct Codes: GPSL and GPSXL3; TVT DevicesProduct Codes: 810041A, 810041B, 810081, TVTRL, TVTOML ARTG Number: 99193 (TVT) & 165075 (Gynemesh PS)
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd