China NMPA Product Recall - Double fixing screw system

Smith & Nephew Inc. initiated a voluntary Class II recall on January 15, 2020, for its Dual Fixation Screw Systems, impacting specific models and batches. This action was reported by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. to the National Medical Products Administration (NMPA). The recall stems from a critical product safety concern where the protective sleeve designed for the device may detach within the sterile packaging. This detachment poses a significant risk, as it can cause the device's tip to puncture the sterile barrier, compromising the sterility of the product before use. Such a breach in sterility directly impacts patient safety, making the product potentially unsafe for its intended medical application. The NMPA oversees this regulatory action, ensuring that affected products are removed from circulation to mitigate potential health risks. Further comprehensive details regarding the specific models and batch numbers subject to this recall are officially documented in the accompanying Medical Device Recall Event Report Form, providing essential information for affected parties.