| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00314-1 |
| Product Name/Description |
Sealapex Xpress
(calcium hydroxide polymeric root canal sealant)
Part Number: 33639
Lot Number: 5-1310
ARTG Number: 236668 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
A labelling error has been identified with a single lot of Sealapex Xpress. The product’s syringe label correctly identifies the expiration date as 2016-11. Some carton labels incorrectly identify the expiration date as 2017-11. Product used past the correct expiration date of 2016-11 may not perform as intended. Such product may exhibit crystals in the catalyst paste. |
| Recall Action |
Recall |
| Recall Action Instructions |
Kerr Endodontics is requesting distributors to identify customers with affected stock and to forward the customer letter to inform them of the issue. Customers with affected stock are requested to contact SybronEndo Customer Care in order to receive a RMA number to facilitate the return and replacement or credit of their affected products.
This action has been closed out on 05/11/2018 |
| Contact Information |
02 8870 3000 - SybronEndo Customer Care |