China NMPA Product Recall - Locking plate; Intramedullary nail system components (trade name: SYNTHES)

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., in collaboration with manufacturer Synthes GmbH, initiated a voluntary Level II recall of specific locking bone plates and intramedullary nail system components. This action, reported to the National Medical Products Administration (NMPA) on April 21, 2016, followed an internal investigation that discovered potential issues with the packaging. The primary concern was that the outer and inner packaging bags of affected product batches might not have been adequately sealed, thereby risking the sterility of these critical implants. The affected products, including locking bone plates for various fractures and intramedullary nail system components for femoral fractures, were distributed across regions including China, Australia, Japan, and several European countries. While no related complaints or adverse events were reported in China, the potential risks associated with compromised sterility include surgical delays, infection, and adverse tissue reactions. As required actions, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. instructed all affected customers to immediately cease using and return the implicated products, which are subsequently designated for local destruction to prevent further use.