Medical device manufacturer, Stryker GmbH, has issued a medical device safety alert concerning its rHead Radial Head and Uni-Elbow System.
According to the manufacturer, the result of a review of the currently available data of the Stryker rHead Radial Head and Uni-Elbow system was found to be inconclusive to continue supporting the performance of the device. Consequently, the manufacturer has decided to remove the product from the global markets.
Health care professionals that have patients using the Stryker rHead Radial Head / Uni-Elbow Prosthesis System should continue to follow up those patients in accordance with the routine standard of care.
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 27 October 2017