Events

Rappel de Abutment Retrieval Instrument Zirconia CC RP/WP This instrument can be included in Abutment Retrieval Kit.

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Nobel Biocare 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-2015-RN-00572-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-06-26
  • 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-2015-RN-00572-1
  • 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
    An internal investigation by the manufacturer showed that one dimension of the affected instrument is incorrect. therefore this instrument cannot be used to remove the metal adapter as intended.
  • Action
    Nobel Biocare is requesting their customers to cease using the device and to return it to a Nobel Biocare subsidiary and receive a replacement instrument. If the affected instrument is a part of a kit, a Nobel Biocare Representative will contact the customer directly. This action has been closed-out on 03/03/2016.

Device

Abutment Retrieval Instrument Zirconia CC RP/WP This instrument can be included in Abutment Retri...
  • Modèle / numéro de série
    Abutment Retrieval Instrument Zirconia CC RP/WP Reference# 37882Batch# 96149 This instrument can be included in Abutment Retrieval Kit, Reference 37508, batches 814929, 815096, 815140, and 855021.
  • Manufacturer
    Nobel Biocare Australia Pty Ltd

Manufacturer

Nobel Biocare Australia Pty Ltd