Events

Retiro De Equipo (Recall) de Cemented tibial bases size 3

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 Depuy.

¿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
    2006-12-26
  • 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/retrait-de-lots-d-embases-tibiales-de-la-societe-depuy-2
  • 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
    DEPUY company has withdrawn from the market on November 23, 2006 all batches of references 149823003 and 149824003 of the medical device called "cemented tibial bases size 3 - Unicompartimentale Preservation range" following difficulties of assembly of the polyethylene insert in the base tibial. As a precaution, the DEPUY company extends the recall to all sizes 1,2,3,4,5 of these tibial bases that may have the same defect (references specified in the attached letter). No incidents of postoperative disassembly have been reported to date in the world. The company has directly notified the recipients of the incriminated references using the message attached (26/12/2006) (18 KB) validated by Afssaps. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for dissemination, if necessary to the services concerned (surgeons, block supervisors). The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Cemented tibial bases size 3
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Depuy

Manufacturer

Depuy