Events

Retiro De Equipo (Recall) de Disposable Sterile Consumables for PULSAVAC II

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 SAS.

¿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
    2008-02-18
  • 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/retrait-de-lots-de-consommables-steriles-a-usage-unique-pour-systemes-pulsavac-ii-et-pulsavac-iii-societe-zimmer-sas
  • 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    On 14/02/2008, as a precautionary measure, Zimmer SAS has withdrawn from the market all the batches of the references contained in the attached message of the medical devices known as Disposable Sterile Consumables for PULSAVAC II and PULSAVAC III Systems, manufactured by Zimmer Orthopedic Surgical Products, following the presence of silicone stains on the packaging of products manufactured between January 1, 2003 and January 7, 2007. According to the manufacturer, these stains, which do not affect the sterility of the products, may be considered damage to the packaging. The company Zimmer SAS has directly notified the recipients of the incriminated lots with the message attached (14/02/2008) (42 KB) validated by Afssaps. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Disposable Sterile Consumables for PULSAVAC II
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Zimmer SAS

Manufacturer

Zimmer SAS
  • 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