# China NMPA Product Recall - Intramedullary nail system

Source: https://www.keypedia.com/records/china_product_recall/synthes-gmbh/df1a4b63-e966-4558-8564-2959d34a8d18
Source feed: China

> China NMPA product recall for Intramedullary nail system by Synthes GmbH published April 19, 2013. Recall level: . The National Medical Products Administration (NMPA) published a recall notice on April 19, 2013, reg

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH recalls intramedullary nail system
- Company Name: Synthes GmbH
- Publication Date: 2013-04-19
- Product Name: Intramedullary nail system
- Recall Reason: There was an error in the laser etching of item number 473.080; the entire batch's product number was etched as 473.085. (The correct label on the packaging is 473.080.)
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: The National Medical Products Administration (NMPA) published a recall notice on April 19, 2013, regarding specific intramedullary nail systems manufactured by Synthes GmbH. The voluntary recall was initiated due to a manufacturing error: an incorrect product number, 473.085, was laser-etched onto the product instead of the correct number, 473.080. Although the packaging correctly identified the product, this discrepancy led to the recall of affected batches, specifically batch number 5916720. The recall, reported to the State Food and Drug Administration (SFDA), a predecessor to the NMPA, was an overseas action and did not involve the Chinese market. Despite the product's registration in China, no units of the affected batch were imported or sold within the country. However, the NMPA mandated that provincial and municipal food and drug administration departments ensure diligent supervision and management of similar products. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., as the responsible unit in China, formally reported the overseas recall status to the regulatory authorities in March 2013.

Company: https://www.keypedia.com/companies/synthes-gmbh/77a06946-ba7a-4bf2-916a-600eabfb0ce7