Events

Rappel de DURACON ISA MOBILE BEARING KNEE TIBIAL INSERT

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
    109399
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-09-14
  • 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
    A packaging discrepancy was identified in specific lots of stryker's duration packaging. it was found that the outer blister container did not meet stryker's internal packaging specifications: specifically seal width and/or breach of the outer seal. each potentially affected duration packaging unit includes an inner and outer blister container. the inner blister was found intact and product sterility was not compromised.

Device

DURACON ISA MOBILE BEARING KNEE TIBIAL INSERT
  • Modèle / numéro de série
    Model Catalog: 6642-2-216 (Lot serial: ALL); Model Catalog: 6642-2-213 (Lot serial: ALL); Model Catalog: 6642-2-211 (Lot serial: ALL); Model Catalog: 6642-2-209 (Lot serial: ALL); Model Catalog: 6642-2-016 (Lot serial: ALL); Model Catalog: 6642-2-013 (Lot serial: ALL); Model Catalog: 6642-2-011 (Lot serial: ALL); Model Catalog: 6642-2-009 (Lot serial: ALL); Model Catalog: 6481-3-320 (Lot serial: ALL); Model Catalog: 6481-3-324 (Lot serial: ALL); Model Catalog: 6481-3-316 (Lot serial: ALL); Model Catalog: 6481-3-313 (Lot serial: ALL); Model Catalog: 6481-3-310 (Lot serial: ALL); Model Catalog: 6481-3-224 (Lot serial: ALL); Model Catalog: 6481-3-220 (Lot serial: ALL); Model Catalog: 6481-3-216 (Lot serial: ALL); Model Catalog: 6481-3-213 (Lot serial: ALL); Model Catalog: 6481-3-210 (Lot serial: ALL); Model Catalog: 6481-2-140 (Lot serial: ALL); Model Catalog: 6642-3-616 (Lot serial: ALL); Model Catalog: 6642-3-613 (Lot serial: ALL); Model Catalog: 6642-3-611 (Lot serial: ALL); Model Catalog: 6642-3-609 (Lot se
  • Description du dispositif
    DURACON ISA MOBILE BEARING KNEE TIBIAL INSERT
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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