| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00726-1 |
| Product Name/Description |
3M ESPE Filtek Supreme XTE Flowable Restorative (Dental material)
Product Code 4920A2 (Shade A2): Lot # N522403
Product Code 4920A3.5 (Shade A3.5): Lot # N536129
ARTG Number: 149476 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
4/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
Two lots of 3M ESPE Filtek Supreme XTE Flowable Restorative (Ginseng) have been mislabelled. Product labelled A2 shade contains A3.5 shade restorative material, and product labelled A3.5 contains A2 shade restorative material. 3M Australia has advised that there is no health or safety hazard associated with this product. |
| Recall Action |
Recall |
| Recall Action Instructions |
3M is requesting its customers to place the product on hold and return any affected product. |
| Contact Information |
1300 363 878 - 3M Customer Service |