China NMPA Product Recall - Tungsten steel burs

Mani (Beijing) Trading Co., Ltd. initiated a voluntary Class III recall of Tungsten Carbide Needles, a product manufactured by its parent company, MANI, INC. of Japan. The recall, published by the National Medical Products Administration (NMPA) on August 2, 2016, stemmed from self-inspection findings. The primary issues involved labeling discrepancies following a change in product registration information on March 30, 2015. Specifically, the company continued using outdated labels after this date due to delays in its label approval and production preparation processes. These labels also failed to include the production period on the Chinese versions. Furthermore, the agent's address on the labels was not promptly updated during the manufacturing period spanning March 30, 2015, to December 21, 2015. Consequently, Mani Co., Ltd. is undertaking this recall for all affected products, identified under Registration or Filing No.: CFDA (Imported) No. 20132550769. The recall aims to address these non-compliance issues and ensure accurate product information for consumers and regulatory bodies. Details on specific models, specifications, and batches are available in an accompanying Medical Device Recall List.