Events

Retiro De Equipo (Recall) de AutoTac Delivery Handle 400-200 and AutoTac Titanium Tack Starter Kit 400-270 (Dental membrane fixation kit)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por BioHorizons 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-2012-RN-01296-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-12-24
  • 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-01296-1
  • 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
    Biohorizons has found that the cleaning instructions may not be sufficient to remove residual contaminants after surgical use.
  • Acción
    Affected lot numbers are identified in the customer letters sent by BioHorizons Australia. Re-clean the handle and sterilise prior to each use or subsequent re-use following the updated instructions provided with the customer letter. Early version of the AutoTac Handle that cannot be disassembled, cleaned and reassembled following the updated instructions are to be returned to BioHorizons Australia for replacement.

Device

AutoTac Delivery Handle 400-200 and AutoTac Titanium Tack Starter Kit 400-270 (Dental membrane fi...
  • Modelo / Serial
    AutoTac Delivery Handle 400-200 and AutoTac Titanium Tack Starter Kit 400-270 (Dental membrane fixation kit)Multiple lot numbers ARTG number: 132758
  • Manufacturer
    BioHorizons Australia Pty Ltd

Manufacturer

BioHorizons Australia Pty Ltd