Events

Rappel de SCHANZ SCREW

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SYNTHES (CANADA) 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
    129484
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-04-14
  • 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
    Labelling changes have been made to synthes external fixation systems (small medium and large) related to magnetic resonance (mr) conditions as a result of changes in required testing protocols/standard to designate a product mr safe mr conditional and mr unsafe. metal devices are no longer identified as mr safe and as a result synthes external fixation systems are no longer labelled mr safe. the synthes external fixation systems are now identified as mr conditional.

Device

SCHANZ SCREW
  • Modèle / numéro de série
    Model Catalog: 294.55 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.783 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.782 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.779 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.774 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.773 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.772 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.771 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.778 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.777 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.776 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.775 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.775SHA (Lot serial: >10 numbers contact mfg); Model Catalog: 294.776SHA (Lot serial: >10 numbers contact mfg); Model Catalog: 294.777SHA (Lot serial: >10 numbers contact mfg); Model Catalog: 294.779SHA (Lot serial: >10 numbers contact mfg); Model Catalog: 294.7
  • Description du dispositif
    SCHANZ SCREW
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

SYNTHES (CANADA) LTD.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    HC