Type of Product |
Medical Device |
TGA Recall Reference |
RC-2018-RN-00064-1 |
Product Name/Description |
SwishTapered Implant 4.1mmD x12mmL SBM Dual Blast; 4.8mmD Platform
Part Numbers: 934112
Kit/Refill/Syringe Lot Number: 69101
Expiry date: 1 October 2020
ARTG Number: 238870 |
Recall Action Level |
Retail |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
29/01/2018 |
Responsible Entity |
|
Reason/Issue |
Implant Direct, through their Regulatory Affairs reporting process, have found that the extender that is packaged with the SwishTapered Implant have been packaged in the incorrect position (upside down in the plastic retainer). This discrepancy may lead to the possibility of the extender not seating properly in the implant. No reports of injury have been received to date. |
Recall Action |
Recall |
Recall Action Instructions |
Implant Direct is advising users to return any affected product.
This action has been closed out on 18/10/2018 |
Contact Information |
1800 654 953 - Customer Service Support |