Events

Rappel de MENTOR Gel Sizers (Sizer for mammary 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 Johnson & Johnson Medical 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-2014-RN-00600-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-06-04
  • 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-2014-RN-00600-1
  • 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
    A complaint was received for a volume discrepancy between the pad print (500cc) and laser engraved marking and all other product labelling (550cc) on a mentor gel sizer manufactured at mentor leiden. during the bounding investigation, a second lot was identified as having a style discrepancy between pad print (moderate profile, mp) and all other product labelling (moderate plus, m+). misjudging the size or style of an implant can result in asymmetric outcome, which may need additional surgery.
  • Action
    Johnson & Johnson Medical (JJM) is requesting their customers to quarantine the affected stock immediately. Arrangements to return the product can be made by contacting the JJM customer service.

Device

MENTOR Gel Sizers (Sizer for mammary prosthesis)
  • Modèle / numéro de série
    MENTOR Gel Sizers (Sizer for mammary prosthesis)Product Code: RSZ5501 Lot Number: 6680501Product Code: RSZ2751Lot Number: 6749298ARTG Number: 157489
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd