Events

Retiro De Equipo (Recall) de Application Instrument for Sternal ZipFix

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-00924-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-09-03
  • 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-2013-RN-00924-1
  • 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
    There is potential for zipfix implants to loosen if the implant is cut while the tensioning trigger is being squeezed. implants cut under tension can cause deformations in the teeth of the locking mechanism thereby compromising the integrity of the implants. the possibility exists for the zipfix implant to be compromised and loosen after implantation or during the post operative recovery period.
  • Acción
    Customers are requested to contact their local Sales Consultant to arrange for replacement with a 2nd generation Application Instrument. DePuy Synthes has confirmed that all 1st generation applicators in loan sets will be replaced with 2nd generation applicators.

Device

Application Instrument for Sternal ZipFix
  • Modelo / Serial
    Application Instrument for Sternal ZipFixPart Number: 03.501.080Lot Number: All 1st generation Application Instruments - Lots prior to 8100630ARTG Number: 153950
  • Clasificación del producto
    Orthopedic Devices
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd