Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par MATHYS.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 026 03 12 000
  • Date de mise en oeuvre de l'événement
    2012-03-07
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=1544
  • Notes / Alertes
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notes supplémentaires dans les données
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    The assessment of a market notification has revealed a certain insecurity in our markets regarding the correct removal of vitamys implants from the packaging. the three pouches and the sterile barrier are not clearly seen after removal of the cardboard box. this might lead to a handover to the sterile surgical staff after having opened the first pouch. as this first pouch does not represent the sterile barrier, in a worst case scenario there might be a contamination of the sterile surgical staff and surgical field.

Device

RM Pressfit cup vitamys and seleXys inlay vitamys
  • Modèle / numéro de série
    All lot numbers
  • Description du dispositif
    Acetabulum prosthesis
  • Manufacturer
    MATHYS

Manufacturer

MATHYS