# China NMPA Product Recall - Custom-made fixed dentures

Source: https://www.globalkeysolutions.net/records/china_product_recall/hengyang-zhengxiang-aigao-dental-prosthetics-center/8b2b05b2-be5f-4586-b3c2-ab128a762b18
Source feed: China

> China NMPA product recall for Custom-made fixed dentures by Hengyang Zhengxiang Aigao Dental Prosthetics Center published August 06, 2019. Recall level: Level 2. On August 6, 2019, the National Medical Products Administration (NMPA) announced a voluntary Class I

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Hengyang Zhengxiang Aigao Dental Prosthesis Manufacturing Center voluntarily recalls custom-made fixed dentures.
- Company Name: Hengyang Zhengxiang Aigao Dental Prosthetics Center
- Publication Date: 2019-08-06
- Product Name: Custom-made fixed dentures
- Recall Level: Level 2
- Recall Reason: Custom-made fixed dentures do not meet the technical requirements of registered products. In this product spot check, the porosity of clause 4.7 was not up to standard. Specifically, "In the porcelain part of the denture, there are 7 pores with a diameter of 40µm-150µm on the test surface of the sample, which does not meet the requirement of no more than 6 pores."
- Discovering Company: Hengyang Zhengxiang Aigao Dental Prosthetics Center
- Manufacturing Company: Hengyang Zhengxiang Aigao Dental Prosthetics Center
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/hengyang-zhengxiang-aigao-dental-prosthetics-center/bd98e571-d1b7-455c-a754-1a386524d8b4