China NMPA Product Recall - Hernia repair patches, polyester and polylactic acid patches

The National Medical Products Administration (NMPA) issued a notice on October 20, 2016, regarding a voluntary recall initiated by SOFRADIM PRODUCTION, an entity associated with Medtronic. The recall pertains to specific batches of hernia repair patches and polyester and polylactic acid patches (NMPA Registration Certificate Nos. 20153463911 and 20163460459). The core issue identified was the use of incorrect materials during production; affected products were woven from polypropylene and polylactic acid monofilaments instead of the specified polyester and polylactic acid monofilaments. Covidien Medical Devices International Trading (Shanghai) Co., Ltd., the responsible unit in China, reported this issue on September 19, 2016. The company confirmed that the recalled products, impacting regions like Europe, the Middle East, and Africa, were neither sold nor imported into the Chinese market. As a result, no direct corrective actions were required within China. However, the NMPA mandated that provincial regulatory bodies enhance their supervision over similar medical devices to ensure product safety and compliance.