# China NMPA Product Recall - Total Knee Joint System - Zirconium-Niobium Alloy Femoral Condyle

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-inc/498e1b2f-480e-4971-b8d5-ceb8b3a7218b
Source feed: China

> China NMPA product recall for Total Knee Joint System - Zirconium-Niobium Alloy Femoral Condyle by Smith & Nephew Inc. published October 24, 2024. Recall level: Level 2 Recall. Smith & Nephew, Inc., in conjunction with its subsidiary Smith & Nephew Medical Products Internation

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew, Inc. is voluntarily recalling its total knee system – the zirconium-niobium alloy femoral condyle.
- Company Name: Smith & Nephew Inc.
- Publication Date: 2024-10-24
- Product Name: Total Knee Joint System - Zirconium-Niobium Alloy Femoral Condyle
- Recall Level: Level 2 Recall
- Recall Reason: Product packaging issues
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew Inc.
- Summary: Smith & Nephew, Inc., in conjunction with its subsidiary Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., has initiated a voluntary Class II recall for its Total Knee System - Zirconium-Niobium Alloy Femoral Implant. This action was officially reported by the National Medical Products Administration (NMPA) on October 24, 2024. The primary reason for the recall is identified product packaging issues originating at the manufacturing facility. The affected medical device, registered under National Medical Device Registration Certificate No. 20153132542, is a critical component for total knee replacement. While the recall details specific models, specifications, and batches in an accompanying report form, the NMPA emphasizes a crucial point: the products implicated in this particular recall were not imported into China. This clarifies that the immediate impact of this specific recall is outside the Chinese market, though the event is documented by the Chinese regulatory body due to the company's operational presence. The Class II designation indicates that while the product may cause temporary or reversible adverse health consequences, the likelihood of serious health risks is remote. This proactive measure by Smith & Nephew demonstrates its commitment to product quality and patient safety, addressing potential packaging integrity concerns.

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