Events

Retiro De Equipo (Recall) de Device Recall Synthes Craniomaxillofacial (CMF) Distraction System

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 USA HQ, 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
    65670
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1726-2013
  • Fecha de inicio del evento
    2013-06-12
  • Fecha de publicación del evento
    2013-07-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119842
  • 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
    The firm initiated a voluntary recall of the bc distractor body which is part of the craniomaxillofacial (cmf) distractor system, due to a mis-alignment issue. there have been instances reported within the impacted lots in which the slot in the barrel of the bc distractor was rotated such that it was not possible to attach the b-type and c-type foot plates.
  • Acción
    SYNTHES sent an Urgent Notice: Medical Device Recall letter dated June 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to examine their inventory for affected product, remove it from use, and return it to Synthes. If they have affected product they were instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section at the end of the letter and indicate the number of devices found and note the Return Authorization Number and return to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If customers did not have the affected product they were asked to complete the Verification Section and faxt to 610-251-9005. Customers with questions were instructed to call 610-719-5450 or e-mail FieldAction@synthes.com. For questions regarding this recall call 610-719-5450.

Device

Device Recall Synthes Craniomaxillofacial (CMF) Distraction System
  • Modelo / Serial
    Part # 04.315.067 with lot #s 6184270 and/or 22612-04.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including PA, CT, DE, and NY.
  • Descripción del producto
    Synthes CMF Distraction System || The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.
  • Manufacturer
    Synthes USA HQ, Inc.

Manufacturer

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