Events

Rappel de STRAUMANN ORTHO SYSTEM - PALATAL IMPLANT SYSTEM - PALATAL IMPLANT TI

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par STRAUMANN CANADA LIMITED.

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
    14671
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2008-07-28
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Recent testing shows that the transfer piece which accompanies the palatal implant may get stuck on the implant during placement and may only be removed by applying mechanical forces.

Device

STRAUMANN ORTHO SYSTEM - PALATAL IMPLANT SYSTEM - PALATAL IMPLANT TI
  • Modèle / numéro de série
    Model Catalog: 042.336S (Lot serial: lot 1001 catalog # 042.336S); Model Catalog: 042.335S (Lot serial: lot 1001 catalog # 042.336S); Model Catalog: 042.336S (Lot serial: lot 1001 catalog # 042.335S); Model Catalog: 042.335S (Lot serial: lot 1001 catalog # 042.335S); Model Catalog: 042.336S (Lot serial: lot E3289 catalog # 042.335S); Model Catalog: 042.335S (Lot serial: lot E3289 catalog # 042.335S); Model Catalog: 042.336S (Lot serial: lot F3776 catalog # 042.335S); Model Catalog: 042.335S (Lot serial: lot F3776 catalog # 042.335S); Model Catalog: 042.335S (Lot serial: lot F0597 catalog # 042.335S); Model Catalog: 042.335S (Lot serial: lot E5455 catalog # 042.335S); Model Catalog: 042.336S (Lot serial: lot E5455 catalog # 042.335S); Model Catalog: 042.335S (Lot serial: lot F4662 catalog # 042.335S); Model Catalog: 042.336S (Lot serial: lot F4662 catalog # 042.335S); Model Catalog: 042.335S (Lot serial: lot C9930 catalog # 042.335S); Model Catalog: 042.336S (Lot serial: lot C9930 catalog # 042.335S); Model C
  • Description du dispositif
    STRAUMANN PALATAL IMPLANT
  • Manufacturer
    STRAUMANN CANADA LIMITED

Manufacturer

STRAUMANN CANADA LIMITED