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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-01015-1
Product Name/Description Premise Universal Restorative Body Syringe and Unidose, Shade A2
(Dental restorative material to fill cavities)

REFILL - SYRINGE PREMISE A2 (4g)
Part Number: 32618
Lot Numbers: 4941320, 4946443, 4906963

REFILL - UNIDOSE PREMISE A2 (20 tips 0.2g each = 4g)
Part Number: 32651
Lot Numbers: 4908202, 4890805, 4890804, 4890806, 4946447
Recall Action Level Retail
Recall Action Classification Class III
Recall Action Commencement Date 22/09/2014
Responsible Entity Kerr Australia Pty Ltd
Reason/Issue Kerr Australia has received some complaints that the Premise A2 composite are sticky and difficult to use.. Please note that there are no safety issues associated with using this product.
Recall Action Recall
Recall Action Instructions End users are advised that if they have any of the affected product in their inventory to immediately return it to Kerr Australia. This action has been closed-out on 29/02/2016.
Contact Information 1800 643 603 - Kerr Australia Customer Care