Events

Retiro De Equipo (Recall) de Dynamic Locking Screw Stardrive 3.7mm self tapping, length 22-70mm and 5.0mm, length 32-90 mm, Cobalt Chrome (CoCrMo) sterile

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

¿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-2013-RN-00596-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-06-18
  • 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-2013-RN-00596-1
  • 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 manufacturer is recalling dls 3.7mm and 5.0mm following customer complaints of breakages at the distal tip of the pin after successful healing and during planned implant removal of the whole construct. no complaints have been reported by australian customers.
  • Acción
    Customers are requested to quarantine all lots of the 3.7 mm and 5.0 mm Dynamic Locking Screws and contact a Depuy Synthes Trauma sales representative to organise the return of the affected devices. Depuy Synthes is also advising implanting surgeons of the appropriate follow up for patients implanted with the potentially affected Dynamic Locking Screw. For further details, please see http://www.tga.gov.au/safety/alerts-device-dynamic-130704.htm

Device

Dynamic Locking Screw Stardrive 3.7mm self tapping, length 22-70mm and 5.0mm, length 32-90 mm, Co...
  • Modelo / Serial
    Dynamic Locking Screw Stardrive 3.7mm self tapping, length 22-70mm and 5.0mm, length 32-90 mm, Cobalt Chrome (CoCrMo) sterileDynamic Locking Screw Stardrive 3.7mm self tapping, length 22-70mm Cobalt-Chrome Alloy (CoCrMo) sterile, Part numbers: 09.213.22S, 09.213.070SDynamic Locking Screw Stardrive 5.0mm, self-tapping, length 32-90 mm, Cobalt Chrome (CoCrMo) sterilePart number: 09.223.032S, 09.223.090SAll lot numbers are affected
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd