Type of Product |
Medical Device |
TGA Recall Reference |
RC-2016-RN-00621-1 |
Product Name/Description |
Alphadent Ceka-Preciline Dental Devices - Ceka, Revax. Preci-Ball, Preci-Horix. Preci-bar and Preci-Clip
Batch Number: 13091 and subsequent
Manufactured from 13 September 2013
ARTG Number: 108721 |
Recall Action Level |
Retail |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
15/06/2016 |
Responsible Entity |
|
Reason/Issue |
The product recall is implemented by the manufacturer, Alphadent NV as a result of the cancellation of the company's CE Certificate of Conformity. Alphadent NV has not received any injury reports relating either directly or indirectly to the medical devices (Ceka attachments) subject to this recall. However, as a precautionary measure and in order to ensure compliance with applicable legislative requirements, Alphadent NV has decided to initiate a recall of the concerned medical devices manufactured from 13 September 2013 with batch number 13091 and subsequent batches. |
Recall Action |
Recall |
Recall Action Instructions |
Alphadent is advising users to inspect stock and quarantine any remaining stock for return or credit. This action has been closed-out on 07/09/2018. |
Contact Information |
02 9417 6660 - Alphabond Dental |