# China NMPA Product Recall - Total Knee System - Oxinium Femoral Implant

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-inc/bf3d8d63-a87c-4ca2-9c4a-b8c691d7f041/
Source feed: China

> China NMPA product recall for Total Knee System - Oxinium Femoral Implant by Smith & Nephew Inc. published June 09, 2021. Recall level: Level 2 Recall. On June 9, 2021, Smith & Nephew, Inc., a medical device manufacturer based in the USA, initiated a v

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew, Inc. is conducting a voluntary recall of its Total Knee System-Oxinium femoral implant.
- Company Name: Smith & Nephew Inc.
- Publication Date: 2021-06-09
- Product Name: Total Knee System - Oxinium Femoral Implant
- Recall Level: Level 2 Recall
- Recall Reason: Certain models and batches of products have surface damage due to manufacturing errors.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew Inc.
- Summary: On June 9, 2021, Smith & Nephew, Inc., a medical device manufacturer based in the USA, initiated a voluntary Class II recall of its Total Knee System - Oxinium femoral implant. This action was reported to and publicized by the National Medical Products Administration (NMPA) in China. Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. facilitated the reporting of this recall. The critical issue prompting this recall stems from a manufacturing error that led to surface damage on specific models and batches of the Oxinium femoral implant. These affected products are identifiable under Registration Certificate No. 20153132542. Operating within the regulatory framework established by the NMPA, Smith & Nephew is undertaking a comprehensive recall to remove all compromised implants from the market. A Class II recall signifies that while the probability of serious adverse health consequences is remote, the use of or exposure to the product may cause temporary or medically reversible adverse health effects. The required action for Smith & Nephew involves the diligent identification and retrieval of all affected units to mitigate potential risks to patient safety and ensure adherence to medical device quality standards. Detailed information regarding the specific affected specifications and batch numbers is provided in the accompanying Medical Device Recall Event Report Form.

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