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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00983-1
Product Name/Description	NX3 Try-In Gel Syringe Refills, Bleach (dental material used to preview the expected shade of a tooth restoration before final cementation) Part Number: 33660 Syringe Lot Number: 4580333 Autobag Lot Number: 4584609 Expiry date: February 2014 ARTG Number: 176398
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	18/09/2013
Responsible Entity	Kerr Australia Pty Ltd
Reason/Issue	NX3 try-in gels allow for the restorations to be seated temporarily for review of their final appearance prior to cementation. Kerr Australia have received reports that some NX3 Try-In Gel syringes in the affected lot incorrectly contain a polishing paste. As the material in the affected syringe does not match the shade of the cement as it is labeled there is a risk that use of the affected material to evaluate shade prior to cementation may result in an unanticipated final restoration colour requiring the need to remove and repeat the restoration.
Recall Action	Recall
Recall Action Instructions	Kerr Australia is requesting customers to stop using the affected product and return to Kerr Australia for replacement or credit.
Contact Information	1800 643 603 - Kerr Australia Customer Care