Events

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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par 3M Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-01135-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2014-10-21
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01135-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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"".
  • Action
    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...
  • Modèle / numéro de série
    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
  • Société-mère du fabricant (2017)
    3m Company
  • Source
    DHTGA