Medical device manufacturer, Smith & Nephew, Inc., has issued a field safety notice concerning the product recall of certain batches of Trauma Pins and Drills.
Smith & Nephew found that burrs in packaging hinged trays may cause pin holes or fiber tears at or near where the hinges are situated in the tyvek pouch, potentially causing a sterile barrier breach of the products. The affected batches are listed in the attachment.
Although there have been no reports, any device with a violated sterile barrier may present increased risk of intraoperative infection.
According to the local supplier, the affected devices were not distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.