China NMPA Product Recall - Tungsten steel burs

MANI, INC. of Japan and its Chinese subsidiary, Mani (Beijing) Trading Co., Ltd., initiated a Class III voluntary recall of Tungsten Carbide Needles (Registration No.: CFDA (Imported) No. 20132550769) following a self-inspection. The recall stems from labeling non-compliance for products manufactured between March 30, 2015, and December 21, 2015. The primary violations include delays in updating labels after a change in the agent's registered address, continued use of outdated labels, and the omission of production and expiration dates on Chinese labels. These issues contravene the National Medical Products Administration's "Regulations on the Management of Medical Device Instructions and Labels" (Order No. 6) and SFDA [2014] No. 144. Although the product's 15-year shelf life means the labeling errors do not affect product use, required actions include freezing undelivered shipments until labels are corrected, producing new compliant labels for future exports to China, isolating and relabeling existing inventory at the agent's location, and notifying affected customers about the discrepancies.