Events

Retiro De Equipo (Recall) de CHISEL BLADES(used in conjunction with the conventional chisel handle (part 399.540) to cut and shape bone during orthopedic surgery)

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-2015-RN-00418-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-05-18
  • 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-2015-RN-00418-1
  • 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 incorrect label was applied to the product that is the subject of this action. certain lots of the chisel blades that were shipped to your facility may be labeled as “not for human use; for veterinary use only”.
  • Acción
    The incorrect label was applied to the product that is the subject of this action. Certain lots of the Chisel Blades that were supplied may be labelled as “NOT FOR HUMAN USE; FOR VETERINARY USE ONLY” This action has been closed-out on 03/03/2016.

Device

CHISEL BLADES(used in conjunction with the conventional chisel handle (part 399.540) to cut and s...
  • Modelo / Serial
    CHISEL BLADES(used in conjunction with the conventional chisel handle (part 399.540) to cut and shape bone during orthopedic surgery)Chisel Blade, long, width 10 mmP/N: 399.555Lot numbers: A7OA30, T921923, T933948 & 935423 Chisel Blade, long, width 16 mmP/N: 399.565Lot numbers: A7QA37 & T936951Chisel Blade, long, width 25 mmP/N: 399.575Lot numbers: A7OA36, T937762 & T966630P/N: 399.585Lot numbers: A7OA30 & T939691ARTG number: 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes