Events

Retiro De Equipo (Recall) de Hip Prosthesis: Lateral Cemented PF Stem Size 8 and Standard Stemized PF Size 7 (Orthopedic Surgery)

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 Zimmer.

¿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
  • ID del evento
    201416308
  • Fecha
    2014-12-18
  • 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/prothese-de-hanche-tige-pf-cimentee-lateralisee-de-taille-8-et-tige-pf-cimentee-standard-de-taille-7-chirurgie-orthopedique-zimmer-rappel
  • 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
    ANSM has been informed of the implementation of a recall made by Zimmer. The users concerned received the attached mail (18/12/2014) (86 KB). This safety action is registered with the ANSM under n ° 201416308 .. You will have the possibility of consulting its progress report on the Directory of the reports of materiovigilance (18/12/2014) (86 ko) by entering this n ° registration.

Device

Hip Prosthesis: Lateral Cemented PF Stem Size 8 and Standard Stemized PF Size 7 (Orthopedic Surgery)
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Zimmer

Manufacturer

Zimmer
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    LAANSM