# China NMPA Product Recall - Hip prosthesis

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-inc/95c424e7-f076-496f-b4de-aa1fa27de6a8/
Source feed: China

> China NMPA product recall for Hip prosthesis by Smith & Nephew Inc. published June 26, 2017. Recall level: Level 3. Smith & Nephew, Inc., in cooperation with Smith & Nephew Medical Products International Trading (Sha

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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: 2017-06-26
- Product Name: Hip prosthesis
- Recall Level: Level 3
- Recall Reason: The packaging is incorrect. The English label on the outer packaging is 71302804 (28mm Diameter Head with +4mm offset), while the actual product is 71303200 (32mm Diameter Head with +0mm offset).
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew Inc.
- Summary: Smith & Nephew, Inc., in cooperation with Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., initiated a voluntary Class III recall of certain hip prostheses. This action was reported to the National Medical Products Administration (NMPA) on May 15, 2017, with public notification on June 26, 2017. The core issue involved incorrect product packaging where the outer English label specified model 71302804 (28mm Diameter Head with +4mm offset), but the actual product inside was model 71303200 (32mm Diameter Head with a +0mm offset). This labeling discrepancy resulted in a mismatch between the indicated and actual device. Operating within the NMPA's regulatory framework, companies are obligated to report such product anomalies and implement necessary corrective measures. Although initiated by Smith & Nephew, Inc. and reported via its Shanghai agent, this specific recall primarily impacted distribution in Canada and Singapore, with the document explicitly stating it did not affect sales within China. The required action was the voluntary removal of these mislabeled hip prostheses from the affected international markets to mitigate potential risks associated with incorrect device implantation.

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