Events

Retiro De Equipo (Recall) de Zimmer Femoral Heads and Taper

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Zimmer GmbH.

¿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
    17989
  • Fecha de inicio del evento
    2015-01-22
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Zimmer Biomet New Zealand Company, 210 Khyber Pass Road, Grafton, Auckland
  • Causa
    Zimmer identified a subset of products that were manufactured prior to mid-2012 and packaged in a specific configuration that failed a packaging test due to potential compromise of the inner sterile tray. this packaging configuration consists of a double sterile barrier. there are no known incidents where the outer tray was compromised; therefore the device remains sterile when delivered during surgery. this recall is not related to sterility concerns, but rather the removal of any unconsumed product given that the packaging may not have the double sterile barrier as intended.
  • Acción
    Product to be returned to supplier

Device

Zimmer Femoral Heads and Taper
  • Modelo / Serial
    Model: 32 models, Affected: Product distributed between May-2005 through Nov-2014
  • Manufacturer
    Zimmer GmbH

Manufacturer

Zimmer GmbH
  • 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
    NZMMDSA