Medical device manufacturer, Smith & Nephew, Inc., has issued a medical device safety alert concerning ULTRA FAST-FIX Knot Pusher/Suture Cutter, Straight. [Product number: 72201537; Batch number: all batches manufactured from April 2010 to April 2014 which have corresponding expiration dates of April 2015 to April 2019].
The manufacturer's internal investigation has found that the packaging material and design to be insufficient to prevent the ULTRA FAST-FIX Knot Pusher Suture Cutter's sharp edges from potentially puncturing the pouch and rendering the device unsterile.
An unsterile device used during an arthroscopic repair could potentially lead to a post-operative infection.
Product recall is ongoing.
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 5 May 2015