Retiro De Equipo (Recall) de Synthes Hand Switch Electric Pen Drive

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
  • Causa
    Synthes received a complaint from a customer in which the hand switch for the electric pen drive was not labeled correctly. the "on" and "lock" labels were interchanged.
  • Acción
    Synthes sent an Urgent Notice: Medical Device Recall letter dated April 15, 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 examine their inventory for the affected product, remove from inventory, and return them to Synthes immediately for replacement. Customers were instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. Complete the Verification Section at the end of the letter by checking the appropriate box indicating affected product has been located. Return the Verification Form with the product to: Credit/Returns, Synthes 1101 Synthes Avenue Monument, CO 80132 If customers do not have the affected product they should still complete the Verifcation Section at the end of the letter by checking the appropriate box and faxing the document to 610-251-9005 or email to: Customers with questions were instructed to call 610-719-5450 or email For questions regarding this recall call 610-719-5000.


  • Modelo / Serial
    Part Number 05.001.012, lot number AV18166
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada. .
  • Descripción del producto
    Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 || The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery.
  • Manufacturer


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