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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00895-1
Product Name/Description	Navigator Surgical Kit/Tray, Tapered Navigator Surgical Kit/Tray, Contra-Angle Torque Driver Kit, Prosthetic Instrumentation Kit, Prosthetic System Driver Tray (Instrument kits which contains reusable dental instruments/ trays used to hold dental instruments during lab sterilization) Product Code: SGKIT, SGTRAY, SGTIKIT, SGTTRAY, NPSDK0, NCATD0, CATD0, NCATD0C,PSDT1, PSKDO ARTG Numbers: 170743, 100988
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	27/08/2013
Responsible Entity	Biomet 3i Australia Pty Ltd
Reason/Issue	BIOMET 3i recently conducted revised sterilization validation testing on all commercial surgical kits / trays. During these validations, certain surgical kits/trays did not meet the Sterility Assurance Level (SAL) of 10^-6 in all locations using the previously validated steam gravity sterilization method at twenty (20) minutes (testing was conducted at a half cycle time of ten (10) minutes). These devices, however, were shown to achieve an SAL of 10^-6 in all challenged locations using a forty (40) minute exposure (testing was conducted at a half cycle time of twenty (20) minutes).
Recall Action	Recall for Product Correction
Recall Action Instructions	Biomet 3i is providing users with revised sterilisation instructions for the steam gravity sterilisation method. There is no change to the pre-vacuum sterilization method.
Contact Information	1800 802 457 - Biomet 3i Customer Service