Events

Retiro De Equipo (Recall) de 4.0mm Variable Angle, SelfDrilling Hexalobe Screw, 14mm

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 Alphatec Spine, 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
    70958
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1547-2015
  • Fecha de inicio del evento
    2015-04-10
  • Fecha de publicación del evento
    2015-04-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135722
  • 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 intervertebral body - Product Code KWQ
  • Causa
    During a field audit it was discovered by an employee that a 16mm trestle luxe screw has been both laser marked and labeled as a 14mm trestle luxe screw (4.0mm variable angle, self-drilling hexalobe screw, 14mm). as a result the firm recalling the affected lots codes for this mislabeling.
  • Acción
    Alphatec Spine sent an Urgent-Medical Device Recall Notification dated April 7, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm first requested that customers notify their consignees of the recall and the risk, and risk mitigation factors. The firm requests that customers take the following field actions: -Upon receipt of the Field Safety Notice to review inventory to determine if affected screw --part number 71240-14, lot 685904 is in their possession. -If the product is in their possession to please abstain from use and contact Alphatec Spine Customer Service (customerservice@alphatecspine.com) immediately for instructions on how to return the affected product. All shipping instructions will be provided, including replace product and/or credit. -Fill out page 3 of the letter to confirm that they have read the notification and have take all necessary actions stated in the notification. -Return a signed copy using one of the methods below: Mail to: Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 Fax to: 1-800 431-7729 For further questions call ( 760) 431-9286.

Device

4.0mm Variable Angle, SelfDrilling Hexalobe Screw, 14mm
  • Modelo / Serial
    Part Number: 71240-14 Lot: 685904
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Distribution to the states of: KS, LA, TN, NJ, KY, CA, FL, OR, OK, AZ, WI, CO, IN, NH, AR, UT, and AL., and to the countries of : Spain, Japan, Belgium, and Saudi Arabia.
  • Descripción del producto
    4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm || Alphatec Spine || Solutions for the Aging Spine || Trestle Luxe Anterior Cervical Plating System || REF 71240-14 || LOT XXXXXX || Alphatec Spine, Inc. || EN: 4.0MM Variable Angle, Self--Drilling Hexalobe Screw, 14MM (TI-6AL-4V ELI) || NON STERILE || Single Use Only
  • Manufacturer
    Alphatec Spine, Inc.

Manufacturer

Alphatec Spine, Inc.
  • Dirección del fabricante
    Alphatec Spine, Inc., 5818 El Camino Real, Carlsbad CA 92008-8816
  • Empresa matriz del fabricante (2017)
    Alphatec Holdings Inc.
  • Source
    USFDA