# China NMPA Product Recall - Hemiarthroplasty component (trade name: Tandem)

Source: https://www.keypedia.com/records/china_product_recall/smith-nephew-inc/93c01a9a-1bef-43ed-a7bc-a4f8ed46d518
Source feed: China

> China NMPA product recall for Hemiarthroplasty component (trade name: Tandem) by Smith & Nephew Inc. published December 07, 2016. Recall level: Level II. Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. initiated a voluntary Cla

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. voluntarily recalls hemiarthroplasty components.
- Company Name: Smith & Nephew Inc.
- Publication Date: 2016-12-07
- Product Name: Hemiarthroplasty component (trade name: Tandem)
- Recall Level: Level II
- Recall Reason: Due to an error in the manufacturing process, the clasp groove position of the affected product exceeds the product design requirements. This issue may lead to three types of functional failure: 1) In most cases, the prosthesis cannot be successfully assembled during surgical preparation; 2) In rare cases, the ball head is found to be too tight after assembly during surgical preparation; 3) In rare cases, the prosthesis is successfully assembled, but dislocation occurs in the first few weeks after surgery.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Smith & Nephew Inc.
- Summary: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall for specific models (71324038-71324054) of its Hemi-Hip Joint Prosthesis Component, known as Tandem. Reported on September 8, 2016, and publicized by the National Medical Products Administration (NMPA) on December 7, 2016, the recall stems from a manufacturing error. The dimension of the clasp groove position on affected products exceeded design specifications, compromising product integrity. This defect could lead to significant functional complications, including the inability to assemble the prosthesis during surgical preparation, a tight bulbous head after assembly, or, in rare instances, dislocation within weeks following surgery. Approximately 1001 affected units were sold in China, out of 1013 produced globally. Under the NMPA's regulatory oversight, the required action for the company is to notify customers to return all unused affected products to prevent potential patient harm and ensure medical device safety.

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