Events

Retiro De Equipo (Recall) de BIOLOX alumina heads

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 SGM.

¿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
    2005-07-11
  • 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-de-tetes-en-alumine-biolox-de-la-societe-sgm
  • 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
    The SGM company has withdrawn from the market on July 6, 2005 batches 3756, 4233 and 4623 of the medical device called "heads BIOLOX alumina 32 mm medium diameter high diameter" reference SGM 34410 distributed by the companies ASTON Medical, PROCOM, ORSEDIS-SPENCER CRAWFORD , OCEAM and NORD IMPLANT following cases of fractures of these heads. The company has directly notified the recipients of the offending lot with the message attached (11/07/2005) (70 KB) validated and completed by Afssaps. This supplement, written by Afssaps after expert opinion, is a letter of recommendation (11/07/2005) (126 ko) relating to the follow-up of patients. This information is addressed to the directors of health establishments and to the local correspondents of materiovigilance for diffusion, if necessary to the services concerned. This reminder only concerns France.

Device

BIOLOX alumina heads
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    SGM

Manufacturer

SGM
  • Source
    LAANSM