China NMPA Product Recall - Electrosurgical instruments

Integra MicroFrance SAS, through its affiliate Integra Life Sciences (Shanghai) Co., Ltd., initiated a voluntary Class III recall of specific electrosurgical instruments. This recall, reported on April 27, 2020, addresses a critical connection problem between the instrument and its monopole cable. The National Medical Products Administration (NMPA) oversees this action, ensuring compliance with medical device regulations in China. The affected products, which include specific models and batch numbers as detailed in the "Medical Device Recall Event Report Form," possess registration certificate No. 20152014168. The primary issue identified is a functional defect concerning the reliable connection of the electrosurgical instrument. This voluntary recall emphasizes the manufacturer's commitment to patient safety and product quality by proactively addressing a potential malfunction that could impact surgical procedures. All relevant stakeholders are directed to consult the attached recall report for comprehensive details on identifying and returning the impacted devices. The NMPA's role underscores the importance of stringent oversight in maintaining the integrity and safety of medical devices circulating within the market.