Events

Retiro De Equipo (Recall) de Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Zimmer Biomet, 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
    78299
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0070-2018
  • Fecha de inicio del evento
    2017-04-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159084
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
  • Causa
    A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requested by a surgeon. after the device was manufactured and used in the planned surgery, it was discovered internally that the implant assembly had a cocrmo screw included as a component of the implant, which contains nickel.
  • Acción
    The firm contacted the surgeon who received / implanted the device. The product has been implanted, so it is not subject to being returned.

Device

Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee
  • Modelo / Serial
    Part Number: CP116574 Lot Number: 073840
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    This was a custom implant, there was only one (1) unit manufactured and distributed. The product has been implanted, so it is not subject to being returned.
  • Descripción del producto
    Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. || This Rotating Hinged Knee is intended to replace patient anatomy.
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Dirección del fabricante
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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
    USFDA