China NMPA Product Recall - Surgical power system

The National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated by Medtronic Xomed, Inc., reported by Medtronic (Shanghai) Management Co., Ltd. This recall, published on October 29, 2019, pertains to Medtronic Xomed's surgical power systems, specifically those with Registration Certificate Nos. 20172547247 and 20172547249. The primary issue prompting this action is the incorrect labeling of motor serial numbers on these medical devices. The NMPA oversees this regulatory action, ensuring compliance with medical device safety standards in China. A Class III recall indicates that the use of or exposure to a violative product is not likely to cause adverse health consequences. While the document does not specify inspection dates, the recall itself serves as a corrective measure under the NMPA's framework. Medtronic Xomed, Inc. has taken the required action of a voluntary recall to address the labeling discrepancy. Further comprehensive details regarding the specific affected product models, specifications, and batch numbers are documented in the attached 'Medical Device Recall Event Report Form.' This action underscores the company's commitment to product integrity and patient safety, aligning with the regulatory expectations set forth by the NMPA.