Events

Retiro De Equipo (Recall) de "PROFEMUR R" PROX BODY PLASMA SPRAYSTD3 (femoral component of a hip joint prosthesis)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Wright Medical Australia Pty Ltd.

¿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
    RC-2012-RN-01062-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-11-15
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01062-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    The recall is being initiated because there is a label discrepancy that affects the shelf life listed on products manufactured at the toulon, france facility. the product functions as intended, however there is not adequate justification on file to support the packaging shelf life listed on the label. there have been no reported issues related to the packaging integrity or sterility of this product. this recall is being initiated because there is a potential risk to health (such as contamination/infection) that may arise if a packaging integrity failure were to occur.
  • Acción
    Wright Medical advises devices implanted are considered safe and are not required to be revisited.

Device

"PROFEMUR R" PROX BODY PLASMA SPRAYSTD3 (femoral component of a hip joint prosthesis)
  • Modelo / Serial
    "PROFEMUR R" PROX BODY PLASMA SPRAYSTD3 (femoral component of a hip joint prosthesis)Product code: PPW38363Lot Number: X02382954ARTG Number: 154282
  • Manufacturer
    Wright Medical Australia Pty Ltd

Manufacturer

Wright Medical Australia Pty Ltd