Events

Recall of Elements Obturation Unit with Buchanan Heat Pluggers

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Kerr Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2018-RN-00057-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-02-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00057-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / 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)
  • Product Classification
    Dental Devices
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd