Events

Retiro De Equipo (Recall) de Ethicon Physiomesh Composite mesh

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Johnson & Johnson International.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    20208
  • Fecha de inicio del evento
    2016-05-30
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Causa
    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.
  • Acción
    Product to be returned to supplier

Device

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

Manufacturer

Johnson & Johnson International