Retiro De Equipo (Recall) de Natural-Knee II System with Metal-Backed Patella

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 received a single complaint regarding discoloration of a natural-knee ii all poly congruent tibia. an investigation into the event found that the discoloration was caused by oxidation resulting from prolonged exposure to artificial light after being machined by a third party supplier and awaiting completion and sterile packaging at zimmer’s manufacturing facility. it is estimated that the above issue affects less than 2% of natural-knee ii systems.
  • Acción
    Zimmer is notifying implanting surgeons of the potential issue and the implications for implant durability. Zimmer is advising that normal post operative follow-up should be continued. For more details, please see .


  • Modelo / Serial
    Natural-Knee II System with Metal-Backed PatellaBatch Numbers: 61566657, 61587666, 61681080, 61781730, 61676693, 61621642, 61487827, 61740149 & 61650259ARTG Number: 95985 & 100318
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • 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