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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00851-1
Product Name/Description Aquasil Easy Mix Putty (used for taking impressions of teeth)

Item Number: 678120

Lot Number: 151103

ARTG Number: 108321
Recall Action Level Retail
Recall Action Classification Class III
Recall Action Commencement Date 24/06/2016
Responsible Entity Dentsply (Australia) Pty Ltd
Reason/Issue The manufacturer has identified that the affected lot of Aquasil Easy Mix Putty may exhibit setting characteristics which are not normal for this product. The affected products may exhibit an extended set time. There is no risk to patients.
Recall Action Recall
Recall Action Instructions Dentsply is advising users to return any remaining unaffected stock. This action has been closed-out on 02/03/2017.
Contact Information 03 9538 8244 - Dentsply Australia