Events

Retiro De Equipo (Recall) de Elements Obturation Unit with Buchanan Heat Pluggers

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Kerr 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-2018-RN-00057-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-02-13
  • 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-2018-RN-00057-1
  • 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
    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.
  • Acción
    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
  • Modelo / Serial
    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)
  • Clasificación del producto
    Dental Devices
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd