Events

Retiro De Equipo (Recall) de Zimmer Persona Tibial Articular Surface Provisional (TASP) Instruments (Supplied as part of the reusable surgical kit used to aid the surgeon in assessing the thickness of articular surface required)

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-01033-1
  • 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-01033-1
  • 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 the fracture of persona tibial articular surface provisional (tasp) tops and bottoms. based on the investigation results of these complaints, zimmer determined that updates to device labelling associated with the zimmer persona knee system were required to provide additional clarifications relating to the instructions for use of the tasp construct. .
  • Acción
    Zimmer is advisingthat the updated technique for use of the TASP construct and its components can be found on pp. 34-37 of the Persona Surgical Technique (97-5026-001-00, Rev. 8) which includes: • Apply gentle manual pressure without impacting the TASP construct with either a mallet or hand. The TASP construct includes the TASP top, bottom, shim, and Tibial Sizing Plate Handle. • During assembly of the TASP construct, slide the shim in using a direct anterior approach between the TASP top and bottom. To avoid inadvertent separation, maintain slight pressure between the TASP top and bottom while inserting the shim. • Varus/Valgus forces may make it difficult to remove the TASP construct. To aid in the removal of the TASP and prevent breakage, ensure that the joint is in a neutral position when removing the TASP construct. This action has been closed-out on 18/03/2016.

Device

Zimmer Persona Tibial Articular Surface Provisional (TASP) Instruments (Supplied as part of the r...
  • Modelo / Serial
    Zimmer Persona Tibial Articular Surface Provisional (TASP) Instruments (Supplied as part of the reusable surgical kit used to aid the surgeon in assessing the thickness of articular surface required)Multiple part (item) numbersARTG 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