Events

Retiro De Equipo (Recall) de Nobel Replace Conical Connection PMC RP 5.0x13mm( Fully Imbedded Dental Implant – Screw endosteal)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Nobel Biocare 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-2015-RN-00302-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-04-02
  • 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-00302-1
  • 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
    Nobel biocare quality management systems observed an issue with a material used in the packaging of the implants. the packaging component (cap) showed excessive oil which was caused by an issue in production of the raw material (pellets) for manufacturing the caps. nobel biocare's internal analysis has confirmed that this material is not according to the standards. based on the testing performed so far the likelihood that the products cause adverse health consequences is currently considered to be low. the implant batches still at the manufacturing site were restricted for further distribution and placed in quarantine.
  • Acción
    Nobel Biocare requested the customer to return the affected product with batch number 13010296. Nobel Biocare is providing a replacement product. This action was underatken prior to notifying TGA.

Device

Nobel Replace Conical Connection PMC RP 5.0x13mm( Fully Imbedded Dental Implant – Screw endosteal)
  • Modelo / Serial
    Nobel Replace Conical Connection PMC RP 5.0x13mm( Fully Imbedded Dental Implant – Screw endosteal)Batch number: 13010296Article number: 37298ARTG Number: 202090
  • Manufacturer
    Nobel Biocare Australia Pty Ltd

Manufacturer

Nobel Biocare Australia Pty Ltd