Events

Retiro De Equipo (Recall) de Device Recall Synthes Electric Pen Drive (EPD) 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, 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
    70247
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1313-2015
  • Fecha de inicio del evento
    2014-12-19
  • Fecha de publicación del evento
    2015-03-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-05-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132629
  • 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
    In may 2013, the original recall was initiated due to complaints the hand switch for the electric pen drive was not labeled correctly, and the on and lock labels were interchanged.
  • Acción
    Synthes sent an Urgent Medical Device Recall Notice, dated December 19, 2014, to all affected customers to provide updated information on additional lots identified. 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 to obtain a Return Authorization (RA) Number, complete the Verification Section at the end of the letter, and return the Verification Form with the product to: Credit/Returns, Synthes 1101 Synthes Avenue Monument, CO 80132. Customers with questions were instructed to call 610-719-5450 or email FieldAction@synthes.com. For questions regarding this recall call 610-719-5000.

Device

Device Recall Synthes Electric Pen Drive (EPD) System
  • Modelo / Serial
    Part Number  05.001.012  Lot Numbers AV18166 AV19044 AV20666
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Synthes Electric Pen Drive (EPD) System, 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
    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