Events

Rappel de RESTORATION MODULAR HIP SYSTEM - MODULAR CALCAR BODIES

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

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
    78445
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2009-07-03
  • 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
    The third party supplier for material used to manufacture the restoration modular components has demonstrated poor process control which has raised concerns about the quality of the raw material supplied. as a precaution and due to the potential impact on the mechanical properties of the affected products stryker is recalling all products manufactured from material supplied by this supplier.

Device

RESTORATION MODULAR HIP SYSTEM - MODULAR CALCAR BODIES
  • Modèle / numéro de série
    Model Catalog: 6276-4-131 (Lot serial: T80551AA); Model Catalog: 6276-4-221 (Lot serial: T80998AC); Model Catalog: 6276-4-225 (Lot serial: T80551AA); Model Catalog: 6276-4-119 (Lot serial: T80554AA); Model Catalog: 6276-4-123 (Lot serial: T80554AA); Model Catalog: 6276-4-127 (Lot serial: T80554AA); Model Catalog: 6276-4-131 (Lot serial: T80554AA); Model Catalog: 6276-4-221 (Lot serial: T80554AA); Model Catalog: 6276-4-225 (Lot serial: T80554AA); Model Catalog: 6276-4-119 (Lot serial: T80998AA); Model Catalog: 6276-4-123 (Lot serial: T80998AA); Model Catalog: 6276-4-127 (Lot serial: T80998AA); Model Catalog: 6276-4-131 (Lot serial: T80998AA); Model Catalog: 6276-4-221 (Lot serial: T80998AA); Model Catalog: 6276-4-225 (Lot serial: T80998AA); Model Catalog: 6276-4-119 (Lot serial: T80998AC); Model Catalog: 6276-4-123 (Lot serial: T80998AC); Model Catalog: 6276-4-127 (Lot serial: T80998AC); Model Catalog: 6276-4-131 (Lot serial: T80998AC); Model Catalog: 6276-4-127 (Lot serial: T80551AA); Model Catalog: 6276-4-1
  • Description du dispositif
    RESTORATION MODULAR CALCAR BODIES
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Adresse du fabricant
    HAMILTON
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    HC