Events

Retiro De Equipo (Recall) de 8mm Vector TAS Screw and Vector TAS Starter Kit (Orthodontic anchoring screw)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Ormco 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-00775-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-08-07
  • 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-00775-1
  • 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
    Ormco have found that some screws in the affected lot were machined undersized at the top of the threads may potentially cause a weakening of the screw. use of the undersized product may result in breakage of the screw during insertion or removal when torqued, possibly requiring surgical removal of any remaining pieces.
  • Acción
    Customers are asked to return any of the affected stock remaining in the inventory. Ormco is advising users to continue with normal treatment if the 8 mm screw is believed to have already been placed or in treatment. When the screw is ready to be removed, physicians are requested to take special care and to not over-torque the screw on removal. For more details, please see http://www.tga.gov.au/safety/alerts-device-8mmvectorscrew-130809.htm .

Device

8mm Vector TAS Screw and Vector TAS Starter Kit (Orthodontic anchoring screw)
  • Modelo / Serial
    8mm Vector TAS Screw and Vector TAS Starter Kit (Orthodontic anchoring screw)8mm Vector TAS ScrewPart Number: 601-0021Lot Number: 112911Vector TAS Start Kit (10 patient)Part Number: 601-0010Lot Number: 112911 (8mm screws from within the kit)ARTG Number: 145039
  • Manufacturer
    Ormco Pty Ltd

Manufacturer

Ormco Pty Ltd