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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01241-1
Product Name/Description	Silane (dentine adhesive) Part number: NO4EA Lot numbers: 3538939, 3572479, 3601537, 3611227, 3264640, 3657461, 3666325, 4387029, 4424253, 4424254, 4485709, 4492806, 4568212, 4618485, 4653026, 4653027, 4653028, 4761586, 4792641, 4824305, 4862783, 4909767, 4947563, 4949092, 5034160, 5085067, 5155175, 5173162, 5204585, 5224590 & 5286924 ARTG number: 175796
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	21/11/2014
Responsible Entity	Kerr Australia Pty Ltd
Reason/Issue	Kerr Australia Pty Ltd has identified that the Instructions for Use (IFUs) incorrectly state, “Silane is intended to be used as a coupler between the prepared tooth and the cement on the restoration.” The correct Indication is, “Silane is intended to be used as a coupler between the cement and porcelain restoration.” Please be aware that the incorrect indication in the IFU may lead to the possibility of decrease in bond strength and sensitivity.
Recall Action	Recall
Recall Action Instructions	Customers are requested to immediately return any affected units to Kerr Australia. Returned stock will be replaced at no cost. This action has been closed-out on 01/03/2016.
Contact Information	1800 643 603 - Kerr Australia Customer Care