China NMPA Product Recall - Orthodontic appliances

Alignment (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of certain orthodontic appliances following a quality inspection that identified a manufacturing defect. The issue, discovered in 11 units produced between May 15 and July 29, 2021, involved a slight downward shift of the attachment cavitation and gingival incision line. This deviation could potentially cause temporary tooth discomfort or hinder proper appliance fit for patients. The company, also known as Align Technology, proactively addressed this quality concern, emphasizing its commitment to product safety and quality. While no domestic market feedback, complaints, or adverse events related to this specific issue have been reported, Alignment (Shanghai) Trading Co., Ltd. decided to recall the affected products. This action was reported under the National Medical Products Administration (NMPA) regulatory framework, indicating adherence to medical device quality and safety standards in China. The specific models, specifications, and batch numbers of the recalled orthodontic appliances (Registration Certificate No.: 20172636140) are detailed in a supplementary Medical Device Recall Event Report Form. The voluntary recall demonstrates the company's commitment to ensuring patient safety and product efficacy.