Medical device manufacturer, Smith and Nephew, has issued a field safety notice concerning metal and PEEK suture anchors. Many of the affected products are from the BIORAPTOR™, FOOTPRINT, HEALICOIL™ and TWINFIX™ product lines.
According to the manufacturer, there was a class II recall for certain metal and PEEK suture anchors due to a packaging issue. Specifically, the manufacturer has identified pin holes in a small number of pouches, which constitutes a breach of the sterile barrier.
According to the local supplier, Smith and Nephew, the affected devices were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 8 August 2012