China NMPA Product Recall - Angled plate screw system

Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its angle plate screw system, as communicated in a National Medical Products Administration (NMPA) document published on August 27, 2019. This action was mandated within the regulatory framework of the NMPA, with device registration overseen by the Shanghai Food and Drug Administration (Certificate No.: 2019-216). The primary issue triggering the recall was a significant labeling error: the incorrect printing of the production address on the Chinese label of the affected product's outer packaging. This mislabeling pertains to the angle plate screw system, registered under Certificate No.: 20153460234. In response, Smith & Nephew promptly began the recall, necessitating the removal of all impacted products from distribution. While specific inspection dates were not provided, the company's proactive recall serves as a corrective action to ensure compliance with manufacturing and labeling standards. This measure highlights the company's commitment to addressing regulatory discrepancies and maintaining product information accuracy. Further comprehensive details concerning the specific models, specifications, and batch numbers affected by this recall are available in the accompanying "Medical Device Recall Event Report Form." This event underscores the critical importance of meticulous attention to detail in medical device labeling for ensuring regulatory adherence and ultimately safeguarding patient safety.