# China NMPA Product Recall - Oxinuli Femoral Head

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-inc/402cd3bd-a79c-40b1-9482-fc5ab4cd3772/
Source feed: China

> China NMPA product recall for Oxinuli Femoral Head by Smith & Nephew Inc. published April 29, 2021. Recall level: Level 3 Recall. Smith & Nephew Inc., through its subsidiary Smith & Nephew International Trading (Shanghai) Co., Ltd

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew Inc. voluntarily recalls OXINIUM Femoral Head.
- Company Name: Smith & Nephew Inc.
- Publication Date: 2021-04-29
- Product Name: Oxinuli Femoral Head
- Recall Level: Level 3 Recall
- Recall Reason: Because certain models and batches of products may have manufacturing defects that could lead to a higher than expected rate of eccentric white spots in the affected femoral heads.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew Inc.
- Summary: Smith & Nephew Inc., through its subsidiary Smith & Nephew International Trading (Shanghai) Co., Ltd., initiated a voluntary Class III recall of its Oxinuum Femoral Head, as reported to the National Medical Products Administration (NMPA) on April 29, 2021. This regulatory action addresses a manufacturing defect: a processing error affecting specific models and batches of the product. This flaw may lead to a higher than expected eccentricity whitening in the affected femoral heads. The recalled product is identified under Registration Certificate No.: 20163460177. While the full details of the affected models, specifications, and batch numbers are documented in the "Medical Device Recall Event Report Form," the core issue is a quality control lapse during production. The NMPA is overseeing this recall to ensure adherence to medical device safety standards in China. Smith & Nephew's proactive and voluntary recall underscores its commitment to product quality and patient safety, aligning with the NMPA's regulatory framework for managing product-related risks in the medical device industry.

Company: https://www.globalkeysolutions.net/companies/smith-nephew-inc/feb94bf5-8eb9-4a12-b2f7-02767ea39056/