Events

Rappel de SOLIS TRIAL CAGE

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
    65179
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2011-11-07
  • 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
    It was detected in qc control that the hole used to thread the solis trial onto the implant holder was manufactured on the left side of the instrument instead of the right as indicated on the engineering print. this leads to the trial being placed upside down on the handle. the implant handle has markings indicating the cranial and caudal sides on the top and bottom respectively. the nonconforming trials result in the cranial side of the trial being inserted facing caudal.

Device

SOLIS TRIAL CAGE
  • Modèle / numéro de série
    Model Catalog: 8741207 (Lot serial: 10G757); Model Catalog: 8741207 (Lot serial: 08C688); Model Catalog: 8741406 (Lot serial: 08C688); Model Catalog: 8741404 (Lot serial: 08C688); Model Catalog: 8741209 (Lot serial: 08C688); Model Catalog: 8741206 (Lot serial: 08C688); Model Catalog: 8741207 (Lot serial: 10F956); Model Catalog: 8741406 (Lot serial: 10F956); Model Catalog: 8741404 (Lot serial: 10F956); Model Catalog: 8741209 (Lot serial: 10F956); Model Catalog: 8741206 (Lot serial: 10F956); Model Catalog: 8741206 (Lot serial: 91854); Model Catalog: 8741406 (Lot serial: 10G757); Model Catalog: 8741404 (Lot serial: 10G757); Model Catalog: 8741209 (Lot serial: 10G757); Model Catalog: 8741206 (Lot serial: 10G757); Model Catalog: 8741207 (Lot serial: 10G655); Model Catalog: 8741406 (Lot serial: 10G655); Model Catalog: 8741404 (Lot serial: 10G655); Model Catalog: 8741209 (Lot serial: 10G655); Model Catalog: 8741206 (Lot serial: 10G655); Model Catalog: 8741207 (Lot serial: 91854); Model Catalog: 8741406 (Lot serial:
  • Description du dispositif
    SOLIS TRIAL CAGE
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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