# China NMPA Product Recall - Total knee system

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-medical-products-international-trading-shanghai-co-ltd/c0cd3135-3a44-4d95-a428-f5ed25ab345c/
Source feed: China

> China NMPA product recall for Total knee system by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. published July 24, 2020. Recall level: Level 2 Recall. Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. has initiated a voluntary

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. has initiated a voluntary recall of its total knee system.
- Company Name: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Publication Date: 2020-07-24
- Product Name: Total knee system
- Recall Level: Level 2 Recall
- Recall Reason: Due to a review of the raw material production process, some batches of the products in question may have exhibited issues such as material inconsistency.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Summary: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. has initiated a voluntary Class II recall of its Total Knee System due to manufacturing concerns. The recall, reported on July 24, 2020, stems from identified material inconsistencies in specific batches during the raw material production process. This issue prompted the company to take corrective action, prioritizing patient safety and product quality. The recall is being managed under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, which are the primary regulatory bodies governing medical devices in China. The company has directed stakeholders to a "Medical Device Recall Event Report Form" for comprehensive details regarding the affected product models, specifications, and batch numbers. This action underscores the importance of adherence to stringent quality control standards in medical device manufacturing to ensure the safety and efficacy of products distributed to the market.

Company: https://www.globalkeysolutions.net/companies/smith-nephew-medical-products-international-trading-shanghai-co-ltd/838e3e3f-d561-4f82-9b98-419473c58276/