| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00345-1 |
| Product Name/Description |
Respond Wires (Orthodontic wire)
Part numbers: 264-1115, 264-1117, 264-1119, 264-1121, 264-1170, 264-1190
ARTG number: 108455 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
19/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
The product labelling descriptor on the package insert for Respond Wire references dimensions that are different from those of the actual wire. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ormco is advising users of the correct dimensions of the wire. |
| Contact Information |
1800 643 603 - Ormco Customer Care Centre |