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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01273-1
Product Name/Description	Instrument Star Unit ML (Calibration with ICM4) (part of Brainlab Spine & Trauma Navigation System) Brainlab Article Number: 55830-25A Serial Numbers: 1205112016 and 1205112026 ARTG Number: 96517
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	29/11/2013
Responsible Entity	Brainlab Australia Pty Ltd
Reason/Issue	The manufacturer, Brainlab AG has determined that pins of the Instrument Star Unit ML (Calibration with ICM4) with specific serial numbers might have been made using an incorrect material that is not suitable for necessary disinfection and sterilisation of the product. Consequently, the biocompatibility of these specific products cannot be ensured. Pins made of this incorrect material will not withstand the necessary reprocessing procedures described in the Brainlab Cleaning, Disinfection and Sterilisation Guide. The prescribed reprocessing procedures will cause visible corrosion of pins made of this incorrect material. One or multiple pins of each product might be affected. If this corrosion occurs and is not detected by the user, and the device is used during surgery, corroded particles of the pin could, directly or indirectly, enter the patient’s body, potentially leading to infection and serious injury of the patient.
Recall Action	Recall
Recall Action Instructions	Customers are asked to identify the affected Instrument Star Units ML and remove them from clinical use. Brainlab Australia will arrange for affected stock to be recovered and replacement stock or a credit note to be issued.
Contact Information	02 9424 3800 - Brainlab Australia