Events

Retiro De Equipo (Recall) de Device Recall Synthes Trochanteric Fixation Nail

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
    66409
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0474-2014
  • Fecha de inicio del evento
    2013-07-30
  • Fecha de publicación del evento
    2013-12-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122353
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Causa
    Certain lots of trochanteric fixation nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.
  • Acción
    Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 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 take the following actions: Call Syntehs at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section checking the appropriate box indicating affected product has been located. Return the Verfication Form with the product to: Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If no affected product found customers were instructed to take the following steps: Complete the attached Verification Section at the end of the letter by checking the appropriate box indicating no affected product has been located. Return the documents to Synthes by fax to 610-251-9005 or Scan/email: FieldAction@synthes.com. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.

Device

Device Recall Synthes Trochanteric Fixation Nail
  • Modelo / Serial
    Part 456.475S, lot # 7121831 and Part 456.637S, lot #7121832, expiration 11/30/21.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.
  • Descripción del producto
    Synthes Trochanteric Fixation Nail || As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.
  • 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