Events

Rappel de TANDEM INTL BIPOLAR SHELL/LINER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SMITH & NEPHEW INC..

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
    69209
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-09-08
  • 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 affected devices were manufactured with an out of specification retainer groove location. in the event the failure occurs it would be obvious to the user in that the devices would not provide an audible indicator that the poly lock has engaged. in the event the construct is tight the user should notice the limited range of motion. however in the worst case situation if the device gives a false indicator of locking the user would not recognize the failure.

Device

TANDEM INTL BIPOLAR SHELL/LINER
  • Modèle / numéro de série
    Model Catalog: 71324040 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324041 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324057 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324055 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324053 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324054 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324052 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324051 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324050 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324049 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324048 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324047 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324046 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324045 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324044 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71324043 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog:
  • Description du dispositif
    TANDEM INTL BIPOLAR SHELL/LINER
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.