Events

Rappel de Nobel Replace Conical Connection PMC RP 5.0x13mm( Fully Imbedded Dental Implant – Screw endosteal)

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-00302-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-04-02
  • 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-00302-1
  • 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
    Nobel biocare quality management systems observed an issue with a material used in the packaging of the implants. the packaging component (cap) showed excessive oil which was caused by an issue in production of the raw material (pellets) for manufacturing the caps. nobel biocare's internal analysis has confirmed that this material is not according to the standards. based on the testing performed so far the likelihood that the products cause adverse health consequences is currently considered to be low. the implant batches still at the manufacturing site were restricted for further distribution and placed in quarantine.
  • Action
    Nobel Biocare requested the customer to return the affected product with batch number 13010296. Nobel Biocare is providing a replacement product. This action was underatken prior to notifying TGA.

Device

Nobel Replace Conical Connection PMC RP 5.0x13mm( Fully Imbedded Dental Implant – Screw endosteal)
  • Modèle / numéro de série
    Nobel Replace Conical Connection PMC RP 5.0x13mm( Fully Imbedded Dental Implant – Screw endosteal)Batch number: 13010296Article number: 37298ARTG Number: 202090
  • Manufacturer
    Nobel Biocare Australia Pty Ltd

Manufacturer

Nobel Biocare Australia Pty Ltd