| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00057-1 |
| Product Name/Description |
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) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
13/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
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
This action has been closed out on 24/11/2020 |
| Contact Information |
1800 643 603 - Customer Support for Kerr Australia |