China NMPA Product Recall - Injector

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., acting on behalf of manufacturer Synthes GmbH, initiated a voluntary Class II recall for its PFNA blade injector, model 03.010.410. This recall, reported on December 29, 2016, and published by the National Medical Products Administration (NMPA) on January 13, 2017, addresses a critical product defect. Investigations confirmed that the injector's handle separates from the internal shaft due to a partial or complete break at the laser welding point. This issue was identified following product complaints regarding the device's failure during surgical procedures involving implant or bone manipulation. Under this NMPA-guided recall, Johnson & Johnson is notifying all affected customers in China, offering them the choice to return the defective product or, based on a risk-benefit assessment, continue its use until a replacement is available. The 350 affected units imported to China, including 124 sold and 213 consigned, are slated for local destruction or return to the manufacturer to ensure patient safety and product integrity.