China NMPA Product Recall - Custom-made fixed dentures

On August 6, 2019, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Hengyang Zhengxiang Aigao Dental Prosthesis Manufacturing Center for its custom-made fixed dentures. This recall, also reported via the Hunan Provincial Drug Administration, stemmed from a product sampling inspection that identified non-compliance with registered technical requirements. Specifically, Nickel-Chromium Alloy Porcelain Crowns exhibited unacceptable porosity, with 7 pores measuring 40 µm-150 µm found on the test surface, exceeding the allowed maximum of 6 pores. The company attributed this issue to a short production process for a sample used by a testing agency, clarifying that the product, despite the defect, was not expected to pose a threat to human health. In response, the manufacturer established a recall leadership team to manage the affected products. Actions included ensuring single-store storage, clear labeling, and dedicated warehousing for the non-compliant items. Products requiring destruction after quality evaluation are slated for disposal under regulatory supervision. Furthermore, Hengyang Zhengxiang Aigao conducted a comprehensive self-inspection, implemented extensive rectification, and reinforced corrective and preventive measures. The company committed to future adherence to the 'Good Manufacturing Practice for Medical Devices' to maintain rigorous product quality standards.