Events

Retiro De Equipo (Recall) de APC Plus Victory Series Twin Upper Left Cuspid -3T/10A with Distal Hook (Unitek Orthodontic Metal Brackets - Orthodontic bracket, metal)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por 3M 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-2014-RN-01135-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-10-21
  • 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-2014-RN-01135-1
  • 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
    Product content did not match label. a total of 20 boxes (each box contains 5 brackets) of ""apc plus victory series twin upper left cuspid -3t/10a with distal hook, slot size 022"" with lot # ft1dg were supplied to 3 orthodontists (end user) in australia in the period 28 july 2014 - 7 august 2014. outer pack label packaging and individual blisters were labelled correctly. the type of bracket supplied within the blister was not correct. the incorrect bracket was ""apc plus victory series twin upper left/right 1st bicuspid with no hook"" instead of ""apc plus victory series twin upper left cuspid -3t/10a with distal hook, slot size 022"".
  • Acción
    This action was undertaken prior to approval of the recall strategy by the TGA. Orthodontists supplied with the affected lot were notified. Orthodontists returned affected lots and 19 of the 20 boxes were received. 1 box was not returned. The retrieval rate was 95 %. All products returned were in the original packaging (unopened).

Device

APC Plus Victory Series Twin Upper Left Cuspid -3T/10A with Distal Hook (Unitek Orthodontic Metal...
  • Modelo / Serial
    APC Plus Victory Series Twin Upper Left Cuspid -3T/10A with Distal Hook (Unitek Orthodontic Metal Brackets - Orthodontic bracket, metal)ARTG Number: 219341
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

3M Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    3m Company
  • Source
    DHTGA