Events

Retiro De Equipo (Recall) de Zimmer Biomet Ortho GmbH - Optipac Refobacin Plus Bone Cement III

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 Orthopaedics Switzerland GmbH.

¿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
    20865
  • Fecha de inicio del evento
    2016-11-23
  • 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: Zimmer Biomet New Zealand Company, 210 Khyber Pass Road, Grafton, Auckland
  • Causa
    During internal investigation, it was identified that biomet orthopaedics cannot guarantee that the sterilization process for the optipac is fully compliant.
  • Acción
    Product to be returned to supplier

Device

Zimmer Biomet Ortho GmbH - Optipac Refobacin Plus Bone Cement III
  • Modelo / Serial
    Model: , Affected: Optipac 40 Refobacin Plus Bone Cement, Optipac 60 Refobacin Plus Bone Cement, Optipac 80 Refobacin Plus Bone Cement, Optipac-S 40 Refobacin Plus Bone Cement, Optipac-S 60 Refobacin Plus Bone Cement, Optipac-S 80 Refobacin Plus Bone Cement
  • Manufacturer
    Biomet Orthopaedics Switzerland GmbH

Manufacturer

Biomet Orthopaedics Switzerland GmbH
  • 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