Events

Retiro De Equipo (Recall) de Persona Distal Valgus Alignment Guide (supplied as part of the reusable surgical kit)

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-01028-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-09-26
  • 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-01028-1
  • 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 has received complaints related to binding of the distal valgus alignment guide's locking knob. persona distal valgus alignment guide collet locks are seizing in the 'unlocked' position during normal operation. this seizure causes the diameter between the collet pegs to become smaller than that of the 8mm im (intramedullary) rod and prevents the rod from being inserted or removed from the alignment guide rendering the device unusable. the root cause of the binding was determined to be excessive counter-clockwise rotation of the knob when unlocking the device.
  • Acción
    Zimmer determined that additional guidance on the locking/unlocking feature was needed. Zimmer is requesting the customers to review the updated portion of the Persona surgical technique (97-5026-001-00) provided with the customer letter, which details use of the Adjustable Valgus Guide. This action has been closed-out on 07/06/2016.

Device

Persona Distal Valgus Alignment Guide (supplied as part of the reusable surgical kit)
  • Modelo / Serial
    Persona Distal Valgus Alignment Guide (supplied as part of the reusable surgical kit)Item number: 42-5099-004-00ARTG number: 109936
  • 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