Events

Retiro De Equipo (Recall) de Device Recall SLift Implant Guides

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 SpineFrontier, 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
    63075
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0417-2013
  • Fecha de inicio del evento
    2012-08-22
  • Fecha de publicación del evento
    2012-11-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112475
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • Causa
    When using the optional s-lift (also known as s-lif) implant guides without stops, there is a known risk of moving the implant guides, and possibly the implant, too far into the disc space creating the potential for injury to the patient. the instructions for use for the s-lift implant guides will be amended to add the following warning: "care is to be taken to not over insert the implant guides.
  • Acción
    Spine Frontier issued a Correction Notice Letter August 22, 2012 to all affected customers to update the Instructions for Use. The letter identified the affected product, problem and actions to be taken. Customers were Instructed to remove the Instructions for Use they currently have and replace them with the update. The letter instructs customers to complete and return the Response Form to 978-232-3990.

Device

Device Recall SLift Implant Guides
  • Modelo / Serial
    Lot Numbers: 012064-001
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide including the states of: MA and TX.
  • Descripción del producto
    S-Lift Implant Guides (also known as S-LIF) || Compressor Part Number: 11-50223 || Product Usage: || Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant contact the surrounding bone or tissue. In the case of S-LIFT Implant Guides, they are used to place vertebral bodies into the disc space without the body contacting the superior or inferior vertebrae.
  • Manufacturer
    SpineFrontier, Inc.

Manufacturer

SpineFrontier, Inc.
  • Dirección del fabricante
    SpineFrontier, Inc., 500 Cummings Ctr Ste 3500, Beverly MA 01915-6516
  • Empresa matriz del fabricante (2017)
    SpineFrontier, Inc.
  • Source
    USFDA