Instrument Star Unit ML (Calibration with ICM4) (part of Brainlab Spine & Trauma Navigation System) 의 리콜

Recall

RC-2013-RN-01273-1

Class II

2013-11-29

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01273-1

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.

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.