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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 Ormco Pty Ltd
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