Events

Recall of Ethicon Physiomesh Composite mesh

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

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
    20208
  • Event Initiated Date
    2016-05-30
  • 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
    Manufacturer has initiated worldwide medical device removal of product from the market., . health canada issued medical recall recall 25may2016 (ra-58846), . mhra recall 2016/005/025/701/005 -health care practitioners that have treated patients using ethicon physiomesh™ composite mesh should continue to follow those patients in the usual manner.This voluntary recall has been communicated to the u.S. ,food and drug administration (fda) and the european competent authorities.
  • Action
    Product to be returned to supplier

Device

Ethicon Physiomesh Composite mesh
  • Model / Serial
    Model: PHY0715R PHY1015V PHY1515Q PHY1520R PHY1520V PHY2025V PHY2030R PHY2535V PHY3035R and PHY3050R, Affected: All lots
  • Manufacturer
    Johnson & Johnson International

Manufacturer

Johnson & Johnson International