| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00785-1 |
| Product Name/Description |
Zoo Master Pouch 15 5H 3/8" Heavy Elephant Elastics (Elastomeric component used with orthodontic brackets)
Part Number: 635-0066
Lot Numbers: 031333440, 0131337074, 041351746 & 051373335
ARTG Number: 104769 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
8/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
It has been reported that the pouch, which should describe the elastic as a "5H (3/8") 14 oz." on the back actually describes the product as "7B (5/8") 2 oz." elastic instead. Although an inconvenience, there are no safety or efficacy issues involved with this product. |
| Recall Action |
Recall |
| Recall Action Instructions |
Ormco is requesting users return affected devices for replacement. |
| Contact Information |
1800 643 603 - Ormco Customer Care |