China NMPA Product Recall - Locking bone screws

On July 8, 2015, Synthes GmbH initiated a voluntary recall of specific locking bone screws due to a critical packaging error. The manufacturer mistakenly packaged 3.5 mm diameter locking screws with a hexagonal drive groove (model 413.014S, batch 8563136) with screws designed for a pentagonal star drive groove. While visually distinguishable, this discrepancy could lead to incompatibility with surgical tools, causing potential delays if discovered during an operation. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., the distributor in China, reported this recall to the National Medical Products Administration (NMPA) on September 7, 2015. Under the NMPA’s regulatory framework for medical device recalls, the company confirmed that the affected products were not imported or sold within China. Consequently, Johnson & Johnson (Shanghai) indicated that no further investigative or corrective actions would be undertaken locally beyond the initial NMPA reporting. The NMPA advised provincial, autonomous region, and municipal food and drug administrations to enhance their supervision and management of similar products, ensuring continued product safety and compliance.