Events

Retiro De Equipo (Recall) de Device Recall Firebird Spinal Fixation 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 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
    73069
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0797-2016
  • Fecha de inicio del evento
    2016-01-08
  • Fecha de publicación del evento
    2016-02-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142988
  • 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
    Wrench - Product Code HXC
  • Causa
    There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. in worst case, the unexpected drop in torque value may lead to the spinal construct loosening and requiring corrective surgical intervention.
  • Acción
    Affected consignees were notified via an Urgent Medical Device Recall Notification letter, dated 1/8/16. The letter identified the affected device and stated the reason for the recall. The recalling firm requests customers to remove the affected devices from their inventory and cease further distribution or use. Customers whom the devices were further distributed to should be notified that the affected devices cannot be used and must be returned to Orthofix per the instructions provided. The attached Acknowledgement Form should be completed and returned. Customers can contact their local Orthofix representative or customer service for further information, replacements, or disposal instructions.

Device

Device Recall Firebird Spinal Fixation System
  • Modelo / Serial
    BS535418105, BS535419118, BS535420030,  BS535419124, BS562325021, BS535418158, BS535418038, BS535418138, BS535418012, BS535419006, BS535420039,  BS535418127,  BS549024010, BS535419141, BS535418081, BS535418111, BS535418117, BS535420041, BS535418144, BS535420081, BS535419151, BS562325006, BS546825008, BS535418002, BS535418013, BS535418131, BS535420006, BS535420010, BS535420026, BS535420047, BS556219012, BS556219026, BS535418109, BS535420082, BS557717009, and  BS562325023.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, Spain, Italy, and Australia.
  • Descripción del producto
    Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) || Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).
  • 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