China NMPA Product Recall - Mini Universal Locking Plate System

Smith & Nephew, Inc., a medical device manufacturer based in the USA, has initiated a voluntary Class III recall of its Mini Universal Locking Bone Plate System. This recall was formally reported by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. to the National Medical Products Administration (NMPA) in China on November 17, 2023. The fundamental issue prompting this action is the discovery of incorrect packaging for certain units of the affected medical device. This product, registered under National Medical Device Registration Certificate No. 20213130368, is subject to the NMPA's comprehensive regulatory framework governing medical device safety and quality within China. This proactive measure by the company, though not a direct outcome of an NMPA inspection, demonstrates adherence to safety protocols and regulatory expectations. The required actions involve the systematic recall of all impacted product models, specifications, and batch numbers to prevent any potential risks to patients or users that could arise from improper packaging. Further specific details regarding the scope of the recall are documented in the "Medical Device Recall Event Report Form," underscoring the company's commitment to product integrity and patient safety under the NMPA's jurisdiction.