Events

Rappel de TESTICULAR IMPLANT SILICONE ELASTOMER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MEDIHUB INTERNATIONAL 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
    133615
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-12-10
  • 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
    On september 17th 2015 silimed had its ce mark suspended due to the discovery of microscopic particles on the surface of some of its implants tested by tuv in a recent audit. silimed has been given a limit period of 90 days to produce technical reports and treat the non-conformities reported.

Device

TESTICULAR IMPLANT SILICONE ELASTOMER
  • Modèle / numéro de série
    Model Catalog: 3232-050 (Lot serial: 8471004); Model Catalog: 3232-045 (Lot serial: 8471004); Model Catalog: 3232-040 (Lot serial: 8471004); Model Catalog: 3232-030 (Lot serial: 8471004); Model Catalog: 3232-050 (Lot serial: 8474209); Model Catalog: 3232-045 (Lot serial: 8474209); Model Catalog: 3232-040 (Lot serial: 8474209); Model Catalog: 3232-030 (Lot serial: 8474209); Model Catalog: 3232-050 (Lot serial: 8474210); Model Catalog: 3232-045 (Lot serial: 8474210); Model Catalog: 3232-040 (Lot serial: 8474210); Model Catalog: 3232-030 (Lot serial: 8474210); Model Catalog: 3232-050 (Lot serial: 8474211); Model Catalog: 3232-045 (Lot serial: 8474211); Model Catalog: 3232-040 (Lot serial: 8474211); Model Catalog: 3232-030 (Lot serial: 8474211); Model Catalog: 3232-050 (Lot serial: ALL LOTS); Model Catalog: 3232-045 (Lot serial: ALL LOTS); Model Catalog: 3232-040 (Lot serial: ALL LOTS); Model Catalog: 3232-030 (Lot serial: ALL LOTS); Model Catalog: 3521-140 (Lot serial: 4442190); Model Catalog: 3521-120 (Lot ser
  • Description du dispositif
    TESTICULAR IMPLANT SILICONE ELASTOMER
  • Manufacturer
    MEDIHUB INTERNATIONAL INC.

Manufacturer

MEDIHUB INTERNATIONAL INC.
  • Adresse du fabricant
    AJAX
  • Source
    HC