Events

Retiro De Equipo (Recall) de Navigator Surgical Kit/Tray, Tapered Navigator Surgical Kit/Tray, Contra-Angle Torque Driver Kit, Prosthetic Instrumentation Kit, Prosthetic System Driver Tray (Instrument kits which contains reusable dental instruments/ trays used to hold dental instruments during lab sterilization)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Biomet 3i Australia 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-00895-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-08-27
  • 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-2013-RN-00895-1
  • 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
    Biomet 3i recently conducted revised sterilization validation testing on all commercial surgical kits / trays. during these validations, certain surgical kits/trays did not meet the sterility assurance level (sal) of 10^-6 in all locations using the previously validated steam gravity sterilization method at twenty (20) minutes (testing was conducted at a half cycle time of ten (10) minutes). these devices, however, were shown to achieve an sal of 10^-6 in all challenged locations using a forty (40) minute exposure (testing was conducted at a half cycle time of twenty (20) minutes).
  • Acción
    Biomet 3i is providing users with revised sterilisation instructions for the steam gravity sterilisation method. There is no change to the pre-vacuum sterilization method.

Device

Navigator Surgical Kit/Tray, Tapered Navigator Surgical Kit/Tray, Contra-Angle Torque Driver Kit,...
  • Modelo / Serial
    Navigator Surgical Kit/Tray, Tapered Navigator Surgical Kit/Tray, Contra-Angle Torque Driver Kit, Prosthetic Instrumentation Kit, Prosthetic System Driver Tray (Instrument kits which contains reusable dental instruments/ trays used to hold dental instruments during lab sterilization) Product Code: SGKIT, SGTRAY, SGTIKIT, SGTTRAY, NPSDK0, NCATD0, CATD0, NCATD0C,PSDT1, PSKDOARTG Numbers: 170743, 100988
  • Manufacturer
    Biomet 3i Australia Pty Ltd

Manufacturer

Biomet 3i Australia 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