China NMPA Product Recall - NYLON sutures

MANI, INC., through its subsidiary MANI (Beijing) Trading Co., Ltd., has initiated a voluntary Class III recall of specific models and batches of its MANI SUTURES NYLON (Registration Certificate No.: 20172650380). This action, overseen by the National Medical Products Administration (NMPA) and published on June 22, 2021, addresses a documentation issue rather than a direct product defect. The main violation cited is a lack of detailed information concerning the adhesive used, which was not adequately specified in the Japanese listing documents for the affected products. As a Class III recall, this indicates that the use of or exposure to the product is not likely to cause adverse health consequences. The required actions involve identifying and managing the specific affected product models and batches, as detailed in the accompanying "Medical Device Recall Table" and "Medical Device Recall Event Report Form," to ensure regulatory compliance and transparency in medical device information.