China NMPA Product Recall - Tungsten steel burs

Mani, Inc. (Japan), in conjunction with its Chinese subsidiary, Mani (Beijing) Trading Co., Ltd., initiated a voluntary Class III recall on August 2, 2016, for 104,843 boxes of Tungsten Carbide Needles (CFDA (Imported) No. 20132550769). This action followed a self-inspection revealing labeling non-conformities for products produced between March 30, 2015, and December 21, 2015. The main issues involved the continued use of outdated labels after a registered agent's address change on March 30, 2015, and a failure to clearly indicate the production and expiration dates on Chinese labels. Additionally, the agent's updated address was not timely reflected on product packaging during the specified production period. These practices violate the National Medical Products Administration's "Regulations on the Management of Medical Device Instructions and Labels" (Order No. 6) and related SFDA notices concerning medical device registration and labeling. Required actions include freezing shipments of non-compliant products, ensuring all future exports to China bear updated labels in accordance with current regulations, isolating and relabeling existing agent inventory, and issuing notification letters to affected customers. Mani, Inc. emphasized that despite the labeling errors, the product's 15-year shelf life prevents any adverse impact on its normal use.