Events

Rappel de NC and RC screw for Cares Abutment, Zr02 and IFU NC Screw for CARES® Abutment, Zr02 and IFU; article 022.2630RC Screw for CARES® Abutment, Zr02 and IFU; article 022.4630

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Straumann 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-00757-3
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-08-09
  • 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-00757-3
  • 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 customer complaint reports that the article 022.2630 nc screw for cares® abutment, zr02 and ifu contains an incorrect screw. the investigation has confirmed that there has been a mix-up and a limited number of articles 022.2630 nc screw for cares® abutment, zr02 and ifu incorrectly contain an rc screw and 022.4630 rc screw for cares® abutment incorrectly contain an nc screw. all of the affected lots are identified and stopped further shipment however the invesitgation indicates that these incorrect screws have been shipped in 9 cases 027.4650 cares® abutment set rc, ceramic and 87 cases 027.2650 cares® abutment set nc, ceramic and dental laboratory.This recall action was not notified to the tga before it was initiated by straumann pty ltd.
  • Action
    Quarantine and return affected product to the distributors.

Device

NC and RC screw for Cares Abutment, Zr02 and IFU NC Screw for CARES® Abutment, Zr02 and IFU; arti...
  • Modèle / numéro de série
    NC and RC screw for Cares Abutment, Zr02 and IFU NC Screw for CARES® Abutment, Zr02 and IFU; article 022.2630RC Screw for CARES® Abutment, Zr02 and IFU; article 022.4630
  • Manufacturer
    Straumann Pty Ltd

Manufacturer

Straumann Pty Ltd