Events

Retiro De Equipo (Recall) de Optipac Bone Cement

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-2016-RN-01539-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-23
  • 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-01539-1
  • 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
    Through an internal investigation biomet orthopaedics has identified that the sterilisation process for optipac bone cement cannot be guaranteed to be fully compliant. the most probable potential risks related to this sterilisation issue include:- inflammation- pain- early infection- potential swelling around the jointbiomet orthopaedics conducted a review of complaints for the optipac and the reported rate for infections was 0.0004 %.
  • Acción
    Zimmer Biomet is advising customers to immediately locate and remove affected devices, and then return these devices to Zimmer Biomet who will issue credit for returned stock. Zimmer is advising that, based on the current information, there does not appear to be a need for additional patient follow-up beyond the standard patient follow-up. This action has been closed-out on 25/05/2017.

Device

Optipac Bone Cement
  • Modelo / Serial
    Optipac Bone CementOptipac 40 Refobacin Plus Bone CementOptipac 60 Refobacin Plus Bone CementOptipac 80 Refobacin Plus Bone CementOptipac-S 40 Refobacin Plus Bone CementOptipac-S 60 Refobacin Plus Bone CementOptipac-S 80 Refobacin Plus Bone CementAll sizes manufactured since January 2014Multiple Material and Batch NumbersARTG Number: 168753
  • 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