Events

Retiro De Equipo (Recall) de Biomet 3i Tapered Implant Navigator Kit

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Biomet 3i.

¿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
    15292
  • Fecha de inicio del evento
    2013-08-30
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Biomet 3i Australia Pty Ltd (NZ), 16 Huapai Street, Onehunga, Auckland 1061
  • Causa
    Biomet 3i recently conducted revised sterilization validation testing on all commercial surgical kits / trays. during these validations, some models of surgical 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
    Instructions for use to be updated

Device

Biomet 3i Tapered Implant Navigator Kit
  • Modelo / Serial
    Model: Product Code: SGTIKIT, SGTTRAY, Affected: All lots
  • Manufacturer
    Biomet 3i

Manufacturer

Biomet 3i
  • 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
    NZMMDSA