Events

Retiro De Equipo (Recall) de Device Recall Orthofix

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 Orthofix, 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
    66969
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0855-2014
  • Fecha de inicio del evento
    2013-11-26
  • Fecha de publicación del evento
    2014-01-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124351
  • 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
    Appliance, fixation, spinal interlaminal - Product Code KWP
  • Causa
    Orthofix received 6 complaints which resulted in a reportable events due to extended surgical times greater than 30 minutes for the modular screw driver (pn 52-1332). the complaints alleged that the screw driver's collet would malfunction resulting in the surgeon being unable to use the modular screw driver to effectively place modular screws, which may result in a delay of surgery.
  • Acción
    Orthofix sent an Urgent Medical Device Recall Notification letter dated November 26, 2013 by certified mail to distributors. The letter identified the affected product, problem and actions to be taken. The letter instructed distributors to immediately cease any further distribution, return affected products to Orthofix at no cost and complete the attached reply form. For questions contact your local Orthofix representative.

Device

Device Recall Orthofix
  • Modelo / Serial
    Production Identification Numbers: Part Number 52-1332, All Lot Numbers.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Nationwide including (Puerto Rico) and the countries of: Spain, Germany, Australia, Peru, Mexico, Colombia, South Africa, and Israel.
  • Descripción del producto
    Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, || Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument.
  • Manufacturer
    Orthofix, Inc.

Manufacturer

Orthofix, Inc.
  • Dirección del fabricante
    Orthofix, Inc., 3451 Plano Pkwy, Lewisville TX 75056-9453
  • Empresa matriz del fabricante (2017)
    Orthofix International Nv
  • Source
    USFDA