Events

Rappel de Elements Obturation Unit with Buchanan Heat Pluggers

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Kerr 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-2018-RN-00057-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-02-13
  • 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-2018-RN-00057-1
  • 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
    Sybron endo received a recent increase in complaints relating to overheating buchanan heat pluggers only while used with the elements obturation unit (eou). when used in the eou, the affected buchanan heat pluggers exceed sybron endo internal specification and operating temperature specifications provided in the instructions for use (ifu). the heat pluggers tips are intended to heat to 200°c ± 50°c while in down-pack and hot pulp mode, 100°c ± 25°c while in back fill mode and 600°c ± 100°c while in cautery mode. internal testing demonstrated that some tips may exceed 700 °c upon activation, while in any operating mode (down pack, back fill, hot pulp test and cautery mode). when this occurs, the screen will indicate niti and the tip will glow red shortly after activation.
  • Action
    Kerr Australia is requesting users: 1. Inspect your device immediately and quarantine affected stock as outlined in the item numbers above to prevent further use; and 2. Examine current inventory for affected product and check the heat plugger to see if the NiTi icon appears and/or tip turns glowing red. (see instructions below); and 3. If you observe the NiTi icon and/or glowing red heat plugger tip, do not use heat plugger and return to Kerr. Please call customer care; and 4. Always follow the Instructions for Use when using the product

Device

Elements Obturation Unit with Buchanan Heat Pluggers
  • Modèle / numéro de série
    Elements Obturation Unit with Buchanan Heat Pluggers Part Numbers: 973-0322, 952-0004, 952-0003, 952-0005, 952-0006, 952-0007, 952-0031, 973-0219(hot pulp test tip)ARTG Number: 236654 (Kerr Australia - Endodontic obsturation system)
  • Classification du dispositif
    Dental Devices
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd