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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01091-1
Product Name/Description	DGDE DirectGuideTM Drill Extender and kits containing the DGDE Drill Extender Affected Part Numbers: DGDE, CST, RBST, RCST, SPCST, BST, ICST, IBST. Affected Lot Numbers: 61928, 67055, 67345, 64895, 65405, 67474, 67479, 65410, 67474, 65409, 64898, 65357, 64898, 65357, 64898, 65406, 67474, 68254 and 68265, 65408, 64896. ARTG Number: 245673
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	10/11/2015
Responsible Entity	Implant Direct Oceania Pty Ltd
Reason/Issue	There is a possible safety issue with the retention of the drill when the DGDE is in use. This discrepancy may lead to the possibility of the DGDE dropping the drill. The sponsor's current data indicates that the possibility of this occurring is unlikely (less than 0.69%). In the unlikely event that the DGDE drops the drill; there is a risk if the product is in use that the drill can possibly fall onto the patient, or into the patient’s oral cavity. The drill could be ingested or aspirated by the patient and this may lead to surgical intervention.
Recall Action	Recall
Recall Action Instructions	Customers to return the affected products. Sponsor to replace the affected products. This action has been closed-out on 26/08/2016.
Contact Information	1800 654 953 - Implant Direct Oceania Customer Care