Events

Retiro De Equipo (Recall) de Zimmer Natural Nail System Cephalomedullary Lag Screw Inserter Long

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
    57341
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0824-2011
  • Fecha de inicio del evento
    2010-10-29
  • Fecha de publicación del evento
    2010-12-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95899
  • 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
    Intramedullary Fixation Rod and Accessories - Product Code HSB
  • Causa
    The firm has determined that two lots of this instrument were inappropriately manufactured by the supplier. the manufacturing process created a step in the lumen which impedes the lag screw retaining shaft from passing through the lumen without the use of excessive force.
  • Acción
    The firm sent Correction and Removal Notification Immediate Response Required letters via email to consignees. The letter identified the affected product and the reason for the recall. The letters also discussed the clinical implications and required actions. Customers are to complete the inventory certification form and user facility documentation form. Each of the affected accounts will be provided with a new instrument, manufactured with the correct lumen diameter and will secure and return the affected instruments per the attached notification, along with the completed inventory certification form. If any further information is needed, customers are to contact Aimee Wood at 574-372-4463.

Device

Zimmer Natural Nail System Cephalomedullary Lag Screw Inserter Long
  • Modelo / Serial
    Lot Numbers: 00111903 and 07890923.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- USA, including states of MI, NJ, MS, OR, KS, TN, A, UT, and CA and countries of Belgium and Germany, Spain, Italy, Greece, France, UK, and Switzerland.
  • Descripción del producto
    Zimmer Natural Nail System Cephalomedullary Lag Screw Inserter Long, Catalog 00-2490-003-50, Zimmer, Warsaw, IN. || A reusable surgical instrument used for the insertion of a Lag Screw used in the Zimmer Natural Nail system.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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