Events

Retiro De Equipo (Recall) de Device Recall Trabecular Metal" Tibia Stop Drill

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, 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
    65042
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1376-2013
  • Fecha de inicio del evento
    2013-03-27
  • Fecha de publicación del evento
    2013-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117771
  • 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
    Bit, drill - Product Code HTW
  • Causa
    Zimmer is initiating a lot specific recall of the trabecular metal" tibia stop drill due to the potential of the outside diameter being oversized. as a result, there is a potential for the drill to not pass through the applicable drill guide.
  • Acción
    Zimmer sent an "URGENT MEDICAL DEVICE RECALL LETTER" dated April 19, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.

Device

Device Recall Trabecular Metal" Tibia Stop Drill
  • Modelo / Serial
    Part No. 00-5887-052-00; lots 62181290 and 62183430
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. || Used to prepare cylindrical holes in the native tibia.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Dirección del fabricante
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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