Events

Recall of Ethicon Gynemesh PROLENE Soft (PS) Mesh

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Ethicon LLC.

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
    19122
  • Event Initiated Date
    2015-09-22
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Reason
    Following a tga review, johnson & johnson medical (jjm) has updated the instructions for use (ifu)., the key messages include the importance of:, - appropriate patient selection, - surgeon experience, - the need for fully informed patient consent.
  • Action
    Instructions for use to be updated

Device

Ethicon Gynemesh PROLENE Soft (PS) Mesh
  • Model / Serial
    Model: GPSL and GPSXL3, Affected: All lots
  • Manufacturer
    Ethicon LLC

Manufacturer

Ethicon LLC