China NMPA Product Recall - Tungsten steel burs

MANI, INC. of Japan, in collaboration with its Chinese subsidiary Mani (Beijing) Trading Co., Ltd., initiated a voluntary Level III recall for 104,843 boxes of Tungsten Carbide Needles. This recall, reported on August 30, 2016, followed a self-inspection that identified several labeling non-compliance issues for products produced or imported between March 30, 2015, and December 21, 2015. The main violations included the continued use of old labels after a registration information change, the omission of production and expiration dates on Chinese labels, and the failure to promptly update the agent's address on the labels. These issues violated China's "Regulations on the Management of Instructions and Labels for Medical Devices" (SFDA Order No. 6) and other relevant regulatory notices. As required actions, MANI, INC. has ceased shipments of non-compliant products, committed to producing and affixing new, compliant labels for all future exports to China, and will assist distributors in isolating and relabeling existing inventory. Affected customers are being notified through their distributors regarding the labeling discrepancies.