Rappel de ROUND HIGH PROFILE RESTERILIZABLE GEL BREAST IMPLANT SIZER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC..

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
    25664
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-08-14
  • Pays de l'événement
  • 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
    A previously discontinued health canada licensed mentor non-sterile gel breast implant sizer was incorrectly distributed to several customers in canada when the customer order was for the sterile version of the same product. the sterile version of the product is licensed with health canada.

Device

  • Modèle / numéro de série
    Model Catalog: RSZ-4754 (Lot serial: 6657792); Model Catalog: RSZ-7504 (Lot serial: 6571808); Model Catalog: RSZ-4754 (Lot serial: 6571808); Model Catalog: RSZ-7504 (Lot serial: 6492914); Model Catalog: RSZ-4754 (Lot serial: 6492914); Model Catalog: RSZ-7504 (Lot serial: 6406134); Model Catalog: RSZ-4754 (Lot serial: 6406134); Model Catalog: RSZ-7504 (Lot serial: 6434505); Model Catalog: RSZ-4754 (Lot serial: 6434505); Model Catalog: RSZ-7504 (Lot serial: 6623189); Model Catalog: RSZ-4754 (Lot serial: 6623189); Model Catalog: RSZ-7504 (Lot serial: 6652667); Model Catalog: RSZ-4754 (Lot serial: 6652667); Model Catalog: RSZ-7504 (Lot serial: 6656806); Model Catalog: RSZ-4754 (Lot serial: 6656806); Model Catalog: RSZ-7504 (Lot serial: 6659170); Model Catalog: RSZ-4754 (Lot serial: 6659170); Model Catalog: RSZ-7504 (Lot serial: 6665665); Model Catalog: RSZ-4754 (Lot serial: 6665665); Model Catalog: RSZ-7504 (Lot serial: 6657792); Model Catalog: RSZ-5251 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: RSZ-4
  • Description du dispositif
    HIGH PROFILE RESTERILIZABLE SIZER
  • Manufacturer

Manufacturer