Events

Retiro De Equipo (Recall) de Zimmer Air Dermatome II Handpiece (used during skin grafting surgeries)

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-2016-RN-00976-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-25
  • 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-2016-RN-00976-1
  • 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 biomet surgical has received product complaints reporting that the surface coating applied to the device is blistering, peeling and discolouring after usage over time. there have been no injuries associated with the reported complaints. in addition, an independent assessment determined that the blistering, peeling and potentially flaking of the surface coating is not expected to result in any long range health consequences. given that the frequency of this surface coating condition can worsen with age, zimmer biomet is currently making preparations for replacement activities to follow in order to prevent future complaints.
  • Acción
    Zimmer is advising users to inspect the devices before and after each use. If blistering or peeling is observed, discontinue use of the affected device. If an alternative device is not available, at the surgeon's discretion, determine the use of the device as a medical necessity and continue to use. After use, follow the facilities wound irrigation protocol or Zimmer Biomet recommends copious irrigation with a normal saline solution or immersion of the graft in a bowl of normal saline. Zimmer Biomet recommends irrigating the donor site with saline as well. Carefully examine the skin graft and donor site for grey coating flakes and continue to irrigate as necessary. All affected devices will be replaced with unaffected stock when available. This action has been closed out on 20/01/2017.

Device

Zimmer Air Dermatome II Handpiece (used during skin grafting surgeries)
  • Modelo / Serial
    Zimmer Air Dermatome II Handpiece (used during skin grafting surgeries)Item Number: 00-8851-001-00All serial numbers affectedARTG Number: 115929
  • 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