Events

Recall of HERMES EVOLUTION SYSTEME DE GENOU - TIGES FEMORALES DISTALES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CERAVER - LES LABORATOIRES OSTEAL MEDICAL.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    42936
  • Event Risk Class
    II
  • Event Initiated Date
    2014-08-01
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    La reference 5037 presente un etiquetage sur le conditionnement et l'opercule du dispositif sur lequel figure la mention "extension tibiale" a la place de "extension femorale". les lots pour references 5034 et 5044 possedent un etiquetage "extension femorale" conforme sur la boite et pour les etiquettes fournies en supplement en revanche l'etiquette colle sur l'opercule du dispositif porte la mention "extension tibiale".

Device

HERMES EVOLUTION SYSTEME DE GENOU - TIGES FEMORALES DISTALES
  • Model / Serial
    Model Catalog: 5044 (Lot serial: 970779/3042); Model Catalog: 5037 (Lot serial: 970779/3282); Model Catalog: 5037 (Lot serial: 970779/3042); Model Catalog: 5044 (Lot serial: 970779/1471); Model Catalog: 5034 (Lot serial: 970779/1471); Model Catalog: 5037 (Lot serial: 970779/1471); Model Catalog: 5044 (Lot serial: 982699/3282); Model Catalog: 5034 (Lot serial: 982699/3282); Model Catalog: 5037 (Lot serial: 982699/3282); Model Catalog: 5044 (Lot serial: 982699/2282); Model Catalog: 5034 (Lot serial: 982699/2282); Model Catalog: 5037 (Lot serial: 982699/2282); Model Catalog: 5044 (Lot serial: 970767/3042); Model Catalog: 5034 (Lot serial: 970767/3042); Model Catalog: 5037 (Lot serial: 970767/3042); Model Catalog: 5044 (Lot serial: 982699/3042); Model Catalog: 5034 (Lot serial: 982699/3042); Model Catalog: 5037 (Lot serial: 982699/3042); Model Catalog: 5044 (Lot serial: 982699/2042); Model Catalog: 5034 (Lot serial: 982699/2042); Model Catalog: 5037 (Lot serial: 982699/2042); Model Catalog: 5044 (Lot serial: 982
  • Product Description
    HERMES EVOLUTION SYSTEME DE GENOU - TIGES FEMORAL
  • Manufacturer
    CERAVER - LES LABORATOIRES OSTEAL MEDICAL

Manufacturer

CERAVER - LES LABORATOIRES OSTEAL MEDICAL
  • Manufacturer Address
    ROISSY
  • Manufacturer Parent Company (2017)
    Ceraver
  • Source
    HC