China NMPA Product Recall - Bone screws

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a Class II voluntary recall for specific bone screws, as reported to the National Medical Products Administration (NMPA) on June 27, 2016, with the notice published on August 30, 2016. The recall, impacting a global scope, addresses a critical manufacturing defect in products manufactured by Synthes GmbH. The main issue identified is an excessively deep screw head groove, which may cause the screw head to detach from the shaft during removal. This poses significant risks including potential surgical delays, the possibility of screw fragments remaining within the patient's body, adverse tissue reactions, and bone damage during attempts to retrieve residual parts. Although the screws are intended for permanent implantation, the risk during removal procedures is substantial. No related complaints or adverse events in China were reported at the time of the recall. Under NMPA's regulatory framework, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. has implemented corrective actions requiring affected customers to immediately cease using the identified products and arrange for their return. All recalled products are either returned to the manufacturer or destroyed locally to prevent further use and mitigate potential patient harm.