Events

Retiro De Equipo (Recall) de Guide Sleeve, yellow for Trochanteric Fixation Nail Advanced (TFNA) Proximal Femoral Nailing System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

¿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
    RC-2016-RN-00877-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-04
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00877-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    The affected lots of the guide sleeves (part # 03.037.017) may have been manufactured with a slightly larger than specified outer diameter which could prevent the sleeve from going through the trochanteric fixation nail advanced (tfna) aiming arm properly.In the event that guide sleeve does not fit through the tfna aiming arm properly, a surgical delay may occur.
  • Acción
    JJM DePuy Synthes is advising users to locate any potentially affected devices in their facility, and contact their JJM DePuy Synthes representative. The representative will conduct functional testing on all products subject to this notification to determine whether the device is conforming or not. Users should ensure every aiming arm is tested with every guide sleeve within their control and, upon completion, only return the device if the product does not pass the functional test.

Device

Guide Sleeve, yellow for Trochanteric Fixation Nail Advanced (TFNA) Proximal Femoral Nailing System
  • Modelo / Serial
    Guide Sleeve, yellow for Trochanteric Fixation Nail Advanced (TFNA) Proximal Femoral Nailing SystemPart Number: 03.037.017Lot Numbers: 9066435, 9469298, 9542486, 9734863, 9763550, 9768881, 9768882, 9768884, 9768886ARTG Number: 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes