Events

Retiro De Equipo (Recall) de Trauma Implants - intramedullary nailsZ NAIL PF 14mm x 46cm UNIV

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 Biomet 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-2017-RN-00634-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-16
  • 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-2017-RN-00634-1
  • 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 is initiating a recall for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. specifically, multiple test samples from the configuration failed simulated distribution and shipping testing. it is very likely that any damage to the carton box and/or to the outer tray would be detected prior to surgery. the package insert (instructions for use) provided with the device or device system contains a section on sterility. it instructs the user to inspect the package and not use the device if any seal or cavity is damaged. if compromised packaging is detected during surgery, it may result in a slight delay in surgery to obtain another implant. in the unlikely event that compromised packaging is not detected prior to or during surgery by the user, there is a risk of infection.
  • Acción
    Users are advised to assist their Zimmer Biomet sales representative to quarantine all affected product. There are no specific patient monitoring instructions related to this recall that are recommended beyond the surgeons existing surgical follow up protocol.

Device

Trauma Implants - intramedullary nailsZ NAIL PF 14mm x 46cm UNIV
  • Modelo / Serial
    Trauma Implants - intramedullary nailsZ NAIL PF 14mm x 46cm UNIVItem Number: 47-2491-460-14Z NAIL GT 14mm x 46cm RItem Number:47-2492-460-14 Z NAIL GT 14mm X 46cm LItem Number: 47-2492-461-14All Lot Numbers with an expiry date before May 2027ARTG Number: 169891
  • Manufacturer
    Zimmer Biomet Pty Ltd

Manufacturer

Zimmer Biomet 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