Medical device manufacturer, Synthes, has issued a medical device safety alert concerning the following devices:
According to the manufacturer, there is a potential for the Adapter for Colibri and small Adapter for Colibri II and Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the respective products to burst. The captioned device could cause permanent injury to the user and/or patient.
Although preliminary internal tests for this failure mode have determined this scenario is highly unlikely to occur, the manufacturer has decided to remove these products from the field.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 July 2016