Events

Retiro De Equipo (Recall) de Synthes Mandible External Fixator

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 Synthes, 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
    69533
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1009-2015
  • Fecha de inicio del evento
    2014-10-17
  • Fecha de publicación del evento
    2015-01-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130880
  • 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
    External mandibular fixator and/or distractor - Product Code MQN
  • Causa
    Under new testing protocols for mr environment safety and compatibility, metal devices are no longer designated mr safe. some components in the cmf mandible external fixator systems were labeled and/or etched with information indicating they are mr safe. they can no longer be labeled mr safe.
  • Acción
    Urgent notices of medical device labeling updates, dated October 17, 2014 and October 24, 2014 were sent to end users and sales consultants, which described the product, problem, and action to be taken. These consignees were instructed to inspect inventory and remove out-dated labeling inserts and replace with updated labeling information.

Device

Synthes Mandible External Fixator
  • Modelo / Serial
    All lots of part nos.:  04.305.003 04.305.004 04.305.005 04.305.010 04.305.011 04.305.012 03.305.006 04.305.100 04.305.101 04.305.102 04.305.103 04.305.128 04.305.130 04.305.134 04.305.138 04.305.140 04.305.142 03.305.105
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    The Synthes Mandible External Fixator; all lots of part nos.: || 04.305.003 || 04.305.004 || 04.305.005 || 04.305.010 || 04.305.011 || 04.305.012 || 03.305.006 || 04.305.100 || 04.305.101 || 04.305.102 || 04.305.103 || 04.305.128 || 04.305.130 || 04.305.134 || 04.305.138 || 04.305.140 || 04.305.142 || 03.305.105 || 03.305.500 || 03.305.500S || Intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
  • Manufacturer
    Synthes, Inc.

Manufacturer

Synthes, Inc.
  • Dirección del fabricante
    Synthes, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA