China NMPA Product Recall - Medical suture needles

MANI, INC. (Japan) and its Chinese subsidiary, MANI (Beijing) Trading Co., Ltd., initiated a Level III voluntary recall of their medical sutures in China, as reported on November 28, 2016, and published on December 5, 2016, by the National Medical Products Administration (NMPA). The recall stemmed from an issue identified during market sales management where a distributor affixed product labels to original packaging, causing the labeling content to violate the "Regulations on the Management of Instructions and Labels for Medical Devices" (Order No. 6 of the State Food and Drug Administration). It was clarified that this labeling error did not impact the product's normal use. In response, MANI Japan committed to enhancing its distributor oversight and temporarily suspended the offending distributor's sales rights for the MANI brand in mainland China. Affected products, totaling 3000 packs, are to be quarantined and their shipments frozen if still with distributors. For products already delivered to customers, notification letters will be issued through distributors. All recalled products will be collected and disposed of by MANI (Beijing) Trading Co., Ltd.