Events

Retiro De Equipo (Recall) de Synthes Implant Holder for Synfix (TM)LR

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
    66577
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0405-2014
  • Fecha de inicio del evento
    2013-10-08
  • Fecha de publicación del evento
    2013-11-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122642
  • 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 LXH
  • Causa
    Complaints were received which described the synfix lr implant holder breaking at the interface between the implant and the holder.
  • Acción
    Synthes sent an Urgent Notice: Medical Device Notification letter dated October 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to returny any of the affect devices, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section indicating the affected product has been located, also indicate the number of devices found and note the Return Authorization Number. Return the Verification Form to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132 Customers were also instructed to return the Verification Section even if they don't have the affected product. Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.

Device

Synthes Implant Holder for Synfix (TM)LR
  • Modelo / Serial
    all lots of part no. 03.802.039
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Canada .
  • Descripción del producto
    Synthes Implant Holder for Synfix (TM)-LR || the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery
  • 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