# China NMPA Product Recall - Expanded polytetrafluoroethylene facial implants

Source: https://www.globalkeysolutions.net/records/china_product_recall/newsheng-medical-products-shanghai-co-ltd/50021b1e-d34e-4872-b326-13abf1ad0aa6/
Source feed: China

> China NMPA product recall for Expanded polytetrafluoroethylene facial implants by Newsheng Medical Products (Shanghai) Co., Ltd. published February 25, 2019. Recall level: Level 3. Newsheng Medical Products (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its expande

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Newsheng Medical Products (Shanghai) Co., Ltd. is voluntarily recalling expanded polytetrafluoroethylene (ePTFE) facial implants.
- Company Name: Newsheng Medical Products (Shanghai) Co., Ltd.
- Publication Date: 2019-02-25
- Product Name: Expanded polytetrafluoroethylene facial implants
- Recall Level: Level 3
- Recall Reason: The specifications described on the product label use an internally controlled coding system, which is inconsistent with the description on the registration certificate.
- Discovering Company: Newsheng Medical Products (Shanghai) Co., Ltd.
- Manufacturing Company: Newsheng Medical Products (Shanghai) Co., Ltd.
- Summary: Newsheng Medical Products (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its expanded polytetrafluoroethylene (ePTFE) facial implants, as reported on February 25, 2019. This action was taken due to identified inconsistencies between the product label's internal controlled coding method and the description detailed in its official registration certificate (Registration Certificate No.: 20163462352). While the document does not specify immediate safety risks, such discrepancies are critical for maintaining accurate product identification and traceability within the regulatory framework. The National Medical Products Administration (NMPA) oversees such medical device recalls in China, ensuring compliance with established standards. As a required action, Newsheng Medical Products (Shanghai) Co., Ltd. formally reported this recall event, providing comprehensive details on affected product models, specifications, and batch numbers in an accompanying "Medical Device Recall Event Report Form." This voluntary recall by the company demonstrates its commitment to rectifying labeling variances and upholding regulatory responsibilities, crucial for maintaining integrity and trust in medical device products.

Company: https://www.globalkeysolutions.net/companies/newsheng-medical-products-shanghai-co-ltd/7fd76c79-ea40-4fb5-b519-f09c52dd9b7a/