Events

Retiro De Equipo (Recall) de Zimmer Periarticular Femoral Cond Buttress Plate and Zimmer Periarticular Distal Lateral Femoral Locking Plate

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-2013-RN-01250-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-11-26
  • 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-2013-RN-01250-1
  • 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 recently conducted a review of historic packaging validations. based on this review, it was determined that a subset of product packaged at a zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. this testing determined that a packaging tray configuration, consisting of an inner and outer sterile tray, resulted in cosmetic failures related to the visual quality of the seal (homogeneous adhesive transfer). this failure occurred on 3 of 154 tray samples tested and was observed on inner trays only. no physical failures in either peel strength or pressure testing were observed.
  • Acción
    Hospitals are requested to quarantine all affected product in their inventory. Return of affected product can be organised through a Zimmer Sales Representative.

Device

Zimmer Periarticular Femoral Cond Buttress Plate and Zimmer Periarticular Distal Lateral Femoral ...
  • Modelo / Serial
    Zimmer Periarticular Femoral Cond Buttress Plate and Zimmer Periarticular Distal Lateral Femoral Locking PlateAll Lots with an expiration date prior to July 24, 2023FEM COND BUTTRESS PLT, RT: 00-2347-001-12, 14, 16, 18FEM COND BUTTRESS PLT, LT: 00-2347-002-12, 14, 16, 18DIST LAT FEM LOCK PLT, RT: 47-2357-101-14, 18DIST LAT FEM LOCK PLT, LT: 47-2357-102-14, 18
  • 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