Print version of this report
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 Implant Direct Oceania Pty Ltd
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