China NMPA Product Recall - High vacuum bone cement mixer/casing assembly CEMENT MIXING AND DELIVERY SYSTEM

On August 29, 2023, Stryker (Beijing) Medical Devices Co., Ltd. announced a voluntary Class II recall initiated by its manufacturer, Stryker Instruments. This recall pertains to the High Vacuum Bone Cement Mixer/Cannula Assembly, specifically the CEMENT MIXING AND DELIVERY SYSTEM, which is registered under National Medical Device Registration Certificate No. 20172043007. The primary issue identified is the potential for the femoral injection head to detach from the high vacuum bone cement mixer during surgical use, posing a potential risk to patients. The National Medical Products Administration (NMPA) oversees this recall action, confirming the Class II designation which indicates that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Stryker Instruments is undertaking this voluntary recall to address the product defect, with specific details regarding affected models, specifications, and batch numbers contained within a separate Medical Device Recall Event Report Form. This action underscores the company's commitment to product safety and compliance with NMPA regulatory standards, ensuring potentially defective medical devices are removed from circulation to protect public health.