Events

Rappel de Kerr Herculite Ultra Composite Restoratives

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Kerr Corporation.

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
    17206
  • Date de mise en oeuvre de l'événement
    2014-08-28
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Henry Schein New Zealand, 23 William Pickering Drive, Albany, North Shore City, Auckland
  • Cause
    The manufacturer has received complaints that the herculite ultra product may be difficult to extrude or may not perform as intended. investigation of the retained and returned product confirmed that the composite does not extrude easily. additionally, any composite extruded was determined to exhibit signs of dryness and was not workable upon manipulation.
  • Action
    Product to be returned to supplier

Device

Kerr Herculite Ultra Composite Restoratives
  • Modèle / numéro de série
    Model: Part Numbers: 35166, 34348, 34448, 34338, Affected: Specific lots
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation