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

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-inc/7ac9de54-1fef-4238-a172-a7234d244df9/
Source feed: China

> China NMPA product recall for Total Knee System - Oxinium Femoral Implant by Smith & Nephew Inc. published October 17, 2024. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) has announced a voluntary Class II recall initia

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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: 2024-10-17
- Product Name: Total Knee System - Oxinium Femoral Implant
- 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: The National Medical Products Administration (NMPA) has announced a voluntary Class II recall initiated by Smith & Nephew, Inc. concerning its Total Knee System - Zirconium-Niobium Alloy Femoral Implant. The recall, reported on October 17, 2024, by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., stems from identified product packaging issues. This recall affects specific models, specifications, and batches, which are detailed in a supplementary Medical Device Recall Event Report Form. It is important to note that despite the manufacturer being Smith & Nephew, Inc., the affected products associated with this particular recall event were not imported into China. This notification serves to inform the public and relevant stakeholders about the quality control measure being undertaken. The NMPA, responsible for the oversight of medical devices in China, ensures such issues are transparently reported, even when the direct impact on the Chinese market is minimal due to the non-importation of the specific recalled batches. This proactive measure by Smith & Nephew, Inc. underscores a commitment to product safety and quality assurance, aligning with international regulatory best practices for medical device oversight and consumer protection.

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