Medical device manufacturer, Ossur, has issued a medical device safety alert concerning its female adapters on prosthetic feet. The affected devices are identified as follow:
The manufacturer's recent findings suggest that non-Össur female mating adapters connected to Össur ankle male pyramids have caused early failure of the male pyramid connector. This is due to incompatible geometry of the female mating adapters used and/ or improper set up of the prosthesis. Affected users are advised to follow proper set-up procedure according to the instructions for use.
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 16 July 2015