# China NMPA Product Recall - Hip prosthesis

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-inc/2949fffc-34d3-47df-8feb-061764a31681/
Source feed: China

> China NMPA product recall for Hip prosthesis by Smith & Nephew Inc. published November 23, 2017. Recall level: Level 3. Smith & Nephew, Inc. initiated a voluntary Class III recall of certain hip prostheses following a ma

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew, Inc. Active Recall of Hip Prostheses
- Company Name: Smith & Nephew Inc.
- Publication Date: 2017-11-23
- Product Name: Hip prosthesis
- Recall Level: Level 3
- Recall Reason: Due to a manufacturing error, the 36mm-3 femoral head was laser-etched to 36mm+4 and placed in a 36mm+4 femoral head package.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew Inc.
- Summary: Smith & Nephew, Inc. initiated a voluntary Class III recall of certain hip prostheses following a manufacturing error identified by its distributor, Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. The issue, reported on October 30, 2017, and published by the National Medical Products Administration (NMPA) on November 23, 2017, involved a labeling discrepancy where a 36mm-3 femoral head component was erroneously laser-etched as 36mm+4 and subsequently packaged into a 36mm+4 femoral head container. This mislabeling could lead to the incorrect component being used.
The affected products, identified by specific model and batch numbers (e.g., 71303603/71303604, batch 16FM08268), are registered under National Medical Device Registration Certificate 20153463804. The recall primarily impacts regions outside of China, specifically mentioning Russia, with 75 units sold in the affected batches. The company submitted a Medical Device Recall Event Report Form to the relevant Provincial Food and Drug Administration Department, outlining the production error and the voluntary recall action. This proactive measure ensures patient safety by addressing the potential for device mismatch due to the labeling inconsistency.

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