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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01002-1
Product Name/Description TempSpan CMT (Temporary composite dental cement)

Part Number: N69CA

All lot numbers are affected

ARTG Number: 171468
Recall Action Level Retail
Recall Action Classification Class III
Recall Action Commencement Date 27/09/2012
Responsible Entity Kerr Australia Pty Ltd
Reason/Issue The current Directions for Use for TempSpan CMT lists a Working Time that is not indicative of the actual performance of the product. The current Directions for Use lists the Total Working Time as 60 seconds, whereas the minimum working time is 45 seconds.
Recall Action Recall for Product Correction
Recall Action Instructions Updating the directions for use.
Contact Information 1800 643 603 - Kerr Australia Customer Care