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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01409-1
Product Name/Description	Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base Product Number: 41888-04 Serial Numbers: ranging from1267114001 to 1267114070 and 1308615032 ARTG Number: 121094
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	27/10/2016
Responsible Entity	Brainlab Australia Pty Ltd
Reason/Issue	Brainlab has identified that one part of the Femoral and Tibial Cutting Block Adapter Base was made from incorrect material. Consequently, neither biocompatibility nor corrosion resistance of these specific products can be ensured. If corrosion of the Femoral and Tibial Cutting Block Adapter Base occurs and is not detected by the user, and the device is used during surgery, corroded particles could, directly or indirectly, enter the patient’s body and potentially cause tissue irritation or a cytotoxic reaction of the patient. Corrosion may also impair successful reprocessing of this device part, so that residue from previous surgeries could adhere to the corroded material. If not detected by the user and the device is used during surgery, germs could be transferred to the patient and lead to infection of the patient. Brainlab has not received any reports of such corroded products having been used in surgery, nor of any effects on patients, due to this issue.
Recall Action	Recall
Recall Action Instructions	Brainlab is advising users to identify all affected units and remove them from clinical use. They are also advised to dispose them and that they will be provided with a replacement stock. This action has been closed-out on 23/05/2017.
Contact Information	02 9424 3800 - Brainlab Australia