Events

Retiro De Equipo (Recall) de NC and RC screw for Cares Abutment, Zr02 and IFU NC Screw for CARES® Abutment, Zr02 and IFU; article 022.2630RC Screw for CARES® Abutment, Zr02 and IFU; article 022.4630

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Straumann 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-2012-RN-00757-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-08-09
  • 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-2012-RN-00757-3
  • 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
    A customer complaint reports that the article 022.2630 nc screw for cares® abutment, zr02 and ifu contains an incorrect screw. the investigation has confirmed that there has been a mix-up and a limited number of articles 022.2630 nc screw for cares® abutment, zr02 and ifu incorrectly contain an rc screw and 022.4630 rc screw for cares® abutment incorrectly contain an nc screw. all of the affected lots are identified and stopped further shipment however the invesitgation indicates that these incorrect screws have been shipped in 9 cases 027.4650 cares® abutment set rc, ceramic and 87 cases 027.2650 cares® abutment set nc, ceramic and dental laboratory.This recall action was not notified to the tga before it was initiated by straumann pty ltd.
  • Acción
    Quarantine and return affected product to the distributors.

Device

NC and RC screw for Cares Abutment, Zr02 and IFU NC Screw for CARES® Abutment, Zr02 and IFU; arti...
  • Modelo / Serial
    NC and RC screw for Cares Abutment, Zr02 and IFU NC Screw for CARES® Abutment, Zr02 and IFU; article 022.2630RC Screw for CARES® Abutment, Zr02 and IFU; article 022.4630
  • Manufacturer
    Straumann Pty Ltd

Manufacturer

Straumann Pty Ltd