| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00697-1 |
| Product Name/Description |
Damon TMA - Low Friction Archwire (orthodontic wire)
Part Number: 227-1112
Lot Number: 031430923
ARTG Number: 104765 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
30/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
Ormco Corporation received a complaint that the product labelling descriptor on the package for Damon TMA Low Friction Archwires references dimensions that are different from those of the actual wire. The label states that the wire dimension is .017x.020, however the actual dimension is .017x.025. Although the product description on the label is incorrect, the part number, lot number, product packaging and the product within the package are correct. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ormco is advising their customers to be aware of the incorrect information on the package labels. |
| Contact Information |
1800 643 603 - Ormco PTY Customer Care |