Events

Retiro De Equipo (Recall) de UNIVERSAL Modular Electric/Battery Double Trigger Handpiece (Surgical power tool)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Zimmer Pty Ltd.

¿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
    RC-2014-RN-01068-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-10-17
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01068-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Zimmer surgical identified a potential malfunction on the universal modular electric/battery double trigger handpiece. it is possible that the handpiece could start by itself when the power source is connected. the unexpected output of the device (start by itself) could lead to an injury to the user during usage or preparation of the device. the complaint rate for this occurrence is 0.5% per distributed device, and no injuries have been reported.
  • Acción
    To avoid this potential issue (malfunction), Zimmer Surgical is advising customers to implement temporary workaround instructions through the customer letter. Zimmer Surgical, as part of the annual preventive maintenance activities, will upgrade the devices with the new electronics that prevent the “self-start” issue and may also exchange other components as appropriate during the preventive maintenance check. This action has been closed-out on 06/06/2016.

Device

UNIVERSAL Modular Electric/Battery Double Trigger Handpiece (Surgical power tool)
  • Modelo / Serial
    UNIVERSAL Modular Electric/Battery Double Trigger Handpiece (Surgical power tool)Model number: 89-8507-400-00ARTG Number 215808
  • Manufacturer
    Zimmer Pty Ltd

Manufacturer

Zimmer Pty Ltd
  • 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
    DHTGA