China NMPA Product Recall - Expanded polytetrafluoroethylene facial implants

Newsheng Medical Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall on February 19, 2019, for its expanded polytetrafluoroethylene (ePTFE) facial implants. This action was taken under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The primary reason for the recall was a discrepancy identified between the internal controlled coding method used on the product labels and the description detailed in the official registration certificate (No. 20163462352). This inconsistency, while not directly reported as a safety hazard, necessitated the recall to ensure adherence to regulatory standards and accurate product identification. The company proactively reported this issue and commenced the retrieval of affected products from the market. Further details regarding specific models, specifications, and batch numbers were made available in an accompanying "Medical Device Recall Event Report Form." The voluntary recall underscores the company's commitment to compliance and product integrity within the medical device industry in China.