# China NMPA Product Recall - Tandem Se System (partial hip joint prosthesis)

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-inc/165b9724-b88c-4abc-a726-ada930b07080/
Source feed: China

> China NMPA product recall for Tandem Se System (partial hip joint prosthesis) by Smith & Nephew Inc. published October 24, 2024. Recall level: Level 2 Recall. On October 24, 2024, the National Medical Products Administration (NMPA) publicly reported a Class I

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew, Inc., a U.S. company, is voluntarily recalling hemiarthroplasty components.
- Company Name: Smith & Nephew Inc.
- Publication Date: 2024-10-24
- Product Name: Tandem Se System (partial hip joint prosthesis)
- Recall Level: Level 2 Recall
- Recall Reason: Assembly problem
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew Inc.
- Summary: On October 24, 2024, the National Medical Products Administration (NMPA) publicly reported a Class II voluntary recall initiated by Smith & Nephew, Inc. The recall specifically concerns the company's Tandem Se System hemi-hip prosthetic components, identified under National Medical Device Registration Certificate No. 20193131696. The decision for this proactive market withdrawal was triggered by an assembly problem discovered within these medical devices. Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. communicated the recall due to issues originating from the manufacturer, Smith & Nephew, Inc. Operating within the NMPA's regulatory framework, this Class II recall signifies a situation where the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. A significant detail of this recall is that the specific batches of the affected Tandem Se System hemi-hip prosthetic components involved were not imported into the Chinese market. The company has made further detailed information, including specific models, specifications, and batch numbers, accessible through a "Medical Device Recall List" and a "Medical Device Recall Event Report Form." This voluntary action reflects the manufacturer's responsibility in maintaining product quality and ensuring patient safety in accordance with global medical device standards.

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