Events

Retiro De Equipo (Recall) de Locking Screw Stardrive 1.5 mm and Cortex Screw Stardrive 1.5mm Cortex Screw Stardrive 1.5 mm, self-tapping, length 8 mm, stainless steel

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-00235-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-03
  • 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-00235-1
  • 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 content of the packaging received may not match the label on the package. the label on the package may indicate a 1.5 mm cortex screw with stardrive recess, self-tapping, length 8 mm, part number 02.214.108 and lot number 9682574. however, the screw in the package may be a 1.5 mm locking screw with stardrive recess, self-tapping, length 8 mm, part number 02.214.008 and lot number 9674525. the difference between these two screws is that the locking screw has a threaded head profile while the cortex screw does not. if the incorrect screw is used, there may be a small surgical delay while a correct screw is located.
  • Acción
    Johnson & Johnson Medical (JJM) is advising users to inspect and quarantine any affected stock and return to JJM. This action has been closed-out on 27/01/2017.

Device

Locking Screw Stardrive 1.5 mm and Cortex Screw Stardrive 1.5mm Cortex Screw Stardrive 1.5 mm, se...
  • Modelo / Serial
    Locking Screw Stardrive 1.5 mm and Cortex Screw Stardrive 1.5mm Cortex Screw Stardrive 1.5 mm, self-tapping, length 8 mm, stainless steel Part Number: 02.214.108 Lot Number: 9682574Locking Screw Stardrive 1.5 mm, self-tapping, length 8 mm, stainless steelPart Number: 02.214.008Lot Number: 9674525 (This lot was not distributed in Australia)ARTG Number: 157068
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes