| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00482-1 |
| Product Name/Description |
Generation 1 Jasper Vektor
Multiple Catalogue and Lot Numbers
ARTG Number: 123576
(TP (Australia) - Orthodontic appliance, attachment) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
17/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
TP Orthodontics has been made aware of incidents of device breakage as a result of stress overload. To date, no reports of serious injury have been received as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
TP Australia is requesting customers:
1. Locate any of the affected lots identified in the table given in the customer letter and quarantine those products; and
2. Return the Generation 1 Jasper Vektor for a replacement Jasper Vektor Generation 2 or for a suitable refund, following the instructions given in the Customer Letter.
This action has been closed out on 16/04/2019 |
| Contact Information |
TP(Australia) Pty. Ltd. at 03 9342 3200 or tpaus@tportho.com |