Events

Retiro De Equipo (Recall) de Device Recall Zimmer Nexgen Complete Knee Solution Fluted Stemmed Tibial Broach

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
    51320
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1262-2009
  • Fecha de inicio del evento
    2009-03-13
  • Fecha de publicación del evento
    2009-05-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-12-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79881
  • 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
    Orthopedic manual surgical instrument - Product Code HTQ
  • Causa
    The surface finish inside of the broach is not to specification and the instrument may corrode if cleaned and sterilized according to instructions.
  • Acción
    Distributors were notified by an "Urgent: Device Recall" letter dated March 13, 2009. The letter described the affected product, reason for recall, health risks and actions for distributors and user facilities. Customers were instructed to quarantine affected instruments and return them to the Zimmer Product Service Department. Distributors were also instructed to provide the name and address of hospitals where the instruments were used so that a copy of the recall letter can be forwarded to the user facilities. Direct questions about this recall to Zimmer, Inc. by calling 800-613-6131.

Device

Device Recall Zimmer Nexgen Complete Knee Solution Fluted Stemmed Tibial Broach
  • Modelo / Serial
    Lot Number 61075338.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, Australia, and Germany.
  • Descripción del producto
    Zimmer Nexgen Complete Knee Solution Fluted Stemmed Tibial Broach, Size 7, 8, nonsterile; REF 5997-61-07. || A reusable cutting instrument that is used in total knee arthroplasty surgery.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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