Events

Retiro De Equipo (Recall) de Device Recall MODEL: Aegis Torque Handle CATALOG NO. : 287110800

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 DePuy 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
    72654
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0454-2016
  • Fecha de inicio del evento
    2015-11-20
  • Fecha de publicación del evento
    2015-12-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141825
  • 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
    Manufacturing error within the torque handle may prohibit some handles from being able to fully assemble with the tightener shaft. the design of the inspection gage does not account for the additional shift length.
  • Acción
    DePuy sent an Urgent Voluntary Product Recall Notification dated November 17, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were asked to do the following: 1. Review inventory located within your facility and quarantine any products listed in this recall notice. Please contact your DePuy Synthes Spine* Sales Consultant to return any inventory located within your facility. 2. Review, complete, sign and return the attached business reply form to in accordance with the directions on the business reply form within 5 business days of receipt of this notification. 3. Forward this notice to anyone in your facility that needs to be informed. 4. If any product listed below has been forwarded to another facility, contact that facility and provide them with this letter. 5. Keep a copy of this notice. For further questions please call (508) 828-3774

Device

Device Recall MODEL: Aegis Torque Handle CATALOG NO. : 287110800
  • Modelo / Serial
    LOT NUMBER: GB0906 GB0707 GB0907 GB58815 GB59244 GB61134
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution to the states of : NC, MI, CO, MD, FL, ID, TX, CA and NY.
  • Descripción del producto
    Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
  • Manufacturer
    DePuy Spine, Inc.

Manufacturer

DePuy Spine, Inc.
  • Dirección del fabricante
    DePuy Spine, Inc., 325 Paramount Dr, Raynham MA 02767-5199
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA