China NMPA Product Recall - Medical suture needles

MANI, INC. and its Chinese subsidiary, MANI (Beijing) Trading Co., Ltd., initiated a voluntary Class III recall of medical suture needles (CFDA (Imported) No. 20142011066) in December 2016, following a recall report on November 28, 2016. The recall stemmed from a compliance issue where distributors had affixed product labels directly to the original packaging. This practice violated the "Regulations on the Management of Instructions and Labels for Medical Devices" (Order No. 6 of the State Food and Drug Administration) in China. The affected products, totaling 3000 packs, were primarily sold within China. The core issue was a labeling inconsistency rather than a product defect, and MANI stated that the error did not adversely affect the normal use of the sutures. However, to uphold product information accuracy and social responsibility, the company undertook corrective measures. These actions included MANI (Beijing) Trading Co., Ltd. collecting and disposing of all recalled products. Additionally, the company will strengthen its management of distributors, temporarily suspending the responsible distributor's sales rights for MANI products in mainland China. Distributors are required to quarantine and freeze existing stock, and customers who have purchased the affected sutures will receive direct notifications from MANI via the distributors.