| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00572-1 |
| Product Name/Description |
Abutment Retrieval Instrument Zirconia CC RP/WP
Reference# 37882
Batch# 96149
This instrument can be included in Abutment Retrieval Kit, Reference 37508, batches 814929, 815096, 815140, and 855021. |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
26/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
An internal investigation by the manufacturer showed that one dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended. |
| Recall Action |
Recall |
| Recall Action Instructions |
Nobel Biocare is requesting their customers to cease using the device and to return it to a Nobel Biocare subsidiary and receive a replacement instrument. If the affected instrument is a part of a kit, a Nobel Biocare Representative will contact the customer directly. This action has been closed-out on 03/03/2016. |
| Contact Information |
1800 804 597 - Customer service |