Events

Retiro De Equipo (Recall) de Biomet 3i Bellatek Encode Healing Abutment

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 Implant Innovations Inc.

¿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
    19551
  • Fecha de inicio del evento
    2015-12-11
  • 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
    Through investigation, biomet 3i determined that a limited number of product pouches may not have been sealed during packaging. the occurrence rate to date of a pouch not being sealed during packaging is approximately 0.008%. in the event the product pouch is unsealed, the sterility of the product contained within the pouch cannot be assured and/or the component may be missing.
  • Acción
    Product to be returned to supplier

Device

Biomet 3i Bellatek Encode Healing Abutment
  • Modelo / Serial
    Model: EHA343, EHA344, EHA346, EHA348, EHA353, EHA354, EHA356, EHA358, EHA443, EHA444, EHA446, EHA448, EHA453, EHA454, EHA456, EHA458, EHA463, EHA464, EHA466, EHA468, EHA473, EHA474, EHA476, EHA478, EHA553, EHA554, EHA556, EHA558, EHA563, EHA564, EHA566, EHA568,, Affected: Expiry dates between Nov-2015 and Nov-2020
  • Manufacturer
    Implant Innovations Inc

Manufacturer

Implant Innovations Inc
  • 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