Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base 의 리콜

Recall

RC-2016-RN-01409-1

Class II

2016-10-27

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01409-1

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.

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.