Events

Retiro De Equipo (Recall) de Trauma Guide Wires, 70cm Ball Tip Guide Wire 2.4mm, Tear Drop Guide Wire

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-00819-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-27
  • 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-00819-1
  • 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
    The design verification for the previous packaging configuration does not cover the 70cm wires. whilst there has not been any complaints involving a breach in sterility, zimmer has completed a design verification to move the 70cm guide wires to a new packaging configuration. as a result, the products packaged in the previous packaging configuration are being retrieved from the market.
  • Acción
    Zimmer is requesting that Customers: 1. Review the notification and ensure affected personnel are aware of the contents; 2. Assist your Zimmer Biomet sales representative by quarantining all affected product; 3. A Zimmer Biomet sales representative will remove the affected product from your facility; 4. Complete the Certificate of Acknowledgement as supplied by Zimmer; 4.a Return a digital copy to RAQA.ANZ@zimmerbiomet.com; and 4.b Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation.

Device

Trauma Guide Wires, 70cm Ball Tip Guide Wire 2.4mm, Tear Drop Guide Wire
  • Modelo / Serial
    Trauma Guide Wires, 70cmBall Tip Guide Wire 2.4mmItem Number: 47-2255-008-003mm x 70cm Tear Drop Guide WireItem Number: 47-2490-098-00Expiry Date: April 2022ARTG Number: 118540
  • 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