Rappel de MEDPOR BARRIER IMPLANT

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
    94010
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-12-29
  • 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
    Stryker has become aware that there is a higher occurrence rate of implant damaged during intra-operative handling. a higher occurrence rate of implants breakage intra-operatively may be experienced. for the barrier sheets a loss of adhesion between the barrier sheet and the porous sheet may be also experienced during intra-operative handling and modification. stryker has become aware that the barrier location is on incorrect side of implant for part number 81036. the barrier is incorrectly situated on the inferior (bottom) surface of the implant instead of the superior (top) surface when the implant is properly oriented in the patient's right orbit.

Device

  • Modèle / numéro de série
    Model Catalog: 9312 (Lot serial: A1402023); Model Catalog: 9305 (Lot serial: A1402023); Model Catalog: 9312 (Lot serial: A1312011); Model Catalog: 9305 (Lot serial: A1312011); Model Catalog: 9312 (Lot serial: A1311044); Model Catalog: 9305 (Lot serial: A1311044); Model Catalog: 9312 (Lot serial: A1311008); Model Catalog: 81036 (Lot serial: A1402020); Model Catalog: 9312 (Lot serial: A1310051); Model Catalog: 9305 (Lot serial: A1310051); Model Catalog: 9312 (Lot serial: 81799); Model Catalog: 9305 (Lot serial: 81799); Model Catalog: 9312 (Lot serial: 77004); Model Catalog: 9305 (Lot serial: 77004); Model Catalog: 9312 (Lot serial: 69698); Model Catalog: 9305 (Lot serial: 69698); Model Catalog: 86001 (Lot serial: A1404026); Model Catalog: 86001 (Lot serial: A1405048); Model Catalog: 81036 (Lot serial: A1405060); Model Catalog: 9305 (Lot serial: A1404010); Model Catalog: 9312 (Lot serial: A1404010); Model Catalog: 9305 (Lot serial: A1403008); Model Catalog: 9312 (Lot serial: A1403008); Model Catalog: 9305 (Lot
  • Description du dispositif
    MEDPOR BARRIER IMPLANT
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    HAMILTON
  • Société-mère du fabricant (2017)
  • Source
    HC