Events

Retiro De Equipo (Recall) de Outlet tubing / arthroscopic suction

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por ConMed Linvatec France.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • Fecha
    2010-09-28
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/tubulures-de-sortie-d-aspiration-arthroscopique-conmed-linvatec-france-retrait-de-lots
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    On 23/09/2010, ConMed Linvatec France withdrew from the market the batches mentioned in the recall letter of the medical device called: Arthroscopic suction / outlet tubing, manufactured by ConMed Linvatec corporation in the United States. As a result of several claims, ConMed Linvatec Corporation has shown that arthroscopic suction / outlet tubing exhibited inversion in their final assembly. This is because the red waste tube and the transparent suction tube are not assembled correctly (reversed) on the clear plastic cassette. The company ConMed Linvatec France has directly notified the recipients of the incriminated lots with the message attached (28/09/2010) (32 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Outlet tubing / arthroscopic suction

Manufacturer

ConMed Linvatec France