# China NMPA Product Recall - Hip system

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-medical-products-international-trading-shanghai-co-ltd/2373f42a-e13c-46ef-b237-73fe38a10cfe/
Source feed: China

> China NMPA product recall for Hip system by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. published April 28, 2020. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) reported on April 28, 2020, a voluntary Class II

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. is voluntarily recalling its acetabular system.
- Company Name: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Publication Date: 2020-04-28
- Product Name: Hip system
- Recall Level: Level 2 Recall
- Recall Reason: Due to manufacturing reasons, some product specifications may not meet design requirements, potentially leading to difficulties in locking during surgery and making installation impossible. A total of 6 complaints of the same failure mode have been received globally.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) reported on April 28, 2020, a voluntary Class II recall initiated by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. The recall involves their Hip Acetabular System. The primary issue stems from manufacturing discrepancies, causing certain product specifications to deviate from design requirements. This defect could lead to significant challenges during surgical procedures, specifically difficulties in intraoperative locking and potential installation failure of the device. The company's decision to recall the product follows the receipt of six global complaints since 2018, all detailing the same mode of failure. While the document does not specify inspection dates, the recall is a direct response to these reported product performance issues. Operating under the NMPA's medical device regulatory framework in China, Smith & Nephew is taking proactive measures to address these quality concerns. The required action involves retrieving the affected products from the market, with specific models, specifications, and batch details outlined in the accompanying Medical Device Recall Event Report Form. This recall underscores the importance of stringent manufacturing quality control in medical device production to ensure patient safety and product efficacy.

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