Events

Rappel de "PROFEMUR R" PROX BODY PLASMA SPRAYSTD3 (femoral component of a hip joint prosthesis)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Wright Medical Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2012-RN-01062-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-11-15
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01062-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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)
  • Modèle / numéro de série
    "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