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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00066-1
Product Name/Description	Brainlab Offset Cup Impactor Universal Model Number: 52856, 52856A ARTG Number: 121094
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	23/01/2015
Responsible Entity	Brainlab Australia Pty Ltd
Reason/Issue	It has been detected that, when the device is reprocessed according to the instructions in the current Brainlab Cleaning, Disinfection and Sterilization Guide (Revision 4.9 and previous), the device may not achieve sterility. The required sterility assurance level (SAL) of 10-6 is not reliably achieved with the currently specified steam sterilization cycles and associated drying times.
Recall Action	Recall for Product Correction
Recall Action Instructions	Brainlab is providing the updated instructions for use to end users. This action has been closed-out on 18/07/2016.
Contact Information	02 9424 3800 - Brainlab