China NMPA Product Recall - Stainless steel orthodontic wire

Meiao Orthodontics (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of its stainless steel orthodontic wires (Registration Certificate No.: NMPA Medical Device (Imported) No. 20142631312). The recall, publicly announced on December 5, 2018, followed a random inspection by the National Medical Products Administration (NMPA) which identified significant non-conformities with the product. The main issues discovered were that the actual diagonal dimensions and bending performance of the orthodontic wires did not align with the company's own registered product standards. This discrepancy was attributed to incorrect data entry during the initial product registration process, resulting in inconsistencies between the physical product specifications and the officially documented standards. Under the regulatory oversight of the NMPA, Meiao Orthodontics (Shanghai) Trading Co., Ltd. is undertaking this recall to address the quality and safety concerns. A Class III recall indicates that while the product violates NMPA regulations, the use of or exposure to the violative product is not likely to cause adverse health consequences. The company has submitted a "Medical Device Recall Event Report Form" detailing the specific models and specifications involved in this corrective action.