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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