Events

Rappel de SuperElastic NiTi Archwires (intended to provide force to the teeth to effect movement in order to alter their position)

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

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-2013-RN-01337-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-12-18
  • 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-2013-RN-01337-1
  • 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 manufacturer has initiated a recall due to a product mislabelling which may result in inefficient treatment of the patient and could require further medical intervention to replace the wire.- product labelled as “upper” may contain “lower” archwires with a red midline mark- product labelled as “lower” may contain “upper” archwires with a black midline mark.
  • Action
    Emergo is advising users to return affected devices for replacement.

Device

SuperElastic NiTi Archwires (intended to provide force to the teeth to effect movement in order t...
  • Modèle / numéro de série
    SuperElastic NiTi Archwires (intended to provide force to the teeth to effect movement in order to alter their position)SE Niti 014 Nat U 100Part Number: 11100141124Lot Number: 41756SE Niti 014 Nat L 100Part Number: 11100141144Lot Number: 41760ARTG Number: 165070
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia