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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00809-3
Product Name/Description TempBond NE (temporary dental cement)

Part Number: 33217 - 5ml Syringe

All lots within shelf life

ARTG Number: 171468
Recall Action Level Retail
Recall Action Classification Class III
Recall Action Commencement Date 9/08/2012
Responsible Entity Kerr Australia Pty Ltd
Reason/Issue Kerr Australia advises that the current Directions for Use for TempBond NE lists a Working Time that is not indicative of the actual performance of the product. More specifically, the current Directions for Use lists the Total Working Time as 90 seconds, while the material actually provides a minimum working time of 60 seconds.
Recall Action Recall for Product Correction
Recall Action Instructions Kerr Australia is providing updated Instructions for Use (IFU)
Contact Information 1800 643 603 - Kerr Australia Customer Care