Events

Rappel de HINTEGRA REVISION TALAR COMPONENT

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

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
    70423
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-02-26
  • 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
    Newdeal sas a company within integra lifesciences group has recently identified through an internal evaluation a risk of damage to the package (external pouch) of the hintegra total ankle prosthesis tibial and talar components during shipping/handling. this damage might lead to a breakage of the sterility barrier of this external pouch thus posing the risk of a potential patient infection.

Device

HINTEGRA REVISION TALAR COMPONENT
  • Modèle / numéro de série
    Model Catalog: 301 121 (Lot serial: ALL LOTS); Model Catalog: 301 200 (Lot serial: ALL LOTS); Model Catalog: 301 202 (Lot serial: ALL LOTS); Model Catalog: 301 203 (Lot serial: ALL LOTS); Model Catalog: 302 125 (Lot serial: ALL LOTS); Model Catalog: 302 124 (Lot serial: ALL LOTS); Model Catalog: 302 123 (Lot serial: ALL LOTS); Model Catalog: 302 122 (Lot serial: ALL LOTS); Model Catalog: 302 121 (Lot serial: ALL LOTS); Model Catalog: 301 125 (Lot serial: ALL LOTS); Model Catalog: 301 124 (Lot serial: ALL LOTS); Model Catalog: 301 123 (Lot serial: ALL LOTS); Model Catalog: 301 122 (Lot serial: ALL LOTS); Model Catalog: 301 201 (Lot serial: ALL LOTS); Model Catalog: 302 206 (Lot serial: ALL LOTS); Model Catalog: 302 205 (Lot serial: ALL LOTS); Model Catalog: 302 204 (Lot serial: ALL LOTS); Model Catalog: 302 203 (Lot serial: ALL LOTS); Model Catalog: 302 202 (Lot serial: ALL LOTS); Model Catalog: 302 201 (Lot serial: ALL LOTS); Model Catalog: 302 200 (Lot serial: ALL LOTS); Model Catalog: 301 206 (Lot serial:
  • Description du dispositif
    HINTEGRA REVISION TALAR COMPONENT
  • Manufacturer
    INTEGRA CANADA ULC.

Manufacturer

INTEGRA CANADA ULC.