China NMPA Product Recall - Locking bone screws

The National Medical Products Administration (NMPA) published a report on July 17, 2013, detailing a voluntary recall initiated by Synthes GmbH for specific locking bone screws (SFDA(I)20103462425(Revised)). This action, reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. in June 2013, stemmed from three complaints regarding incorrect product packaging. The core issue involved a mismatch between the inner and outer packaging for product numbers 413.010S (batch 2747402) and 413.020S (batch 2745382) following a secondary sterilization process. The affected regions include Austria, France, the United Kingdom, Italy, the Netherlands, and Japan. Importantly, the recall was an overseas event and did not involve China; despite the product being registered for import, no units were actually imported or sold domestically. Therefore, the Chinese responsible unit reported the situation to the State Food and Drug Administration (SFDA) but did not undertake further recall measures within China. The NMPA advised provincial food and drug administrations to enhance their supervision of similar medical devices.