# China NMPA Product Recall - Craniofacial internal fixation system

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/ced246e8-4ec3-42a0-8424-4b2ba37220b5/
Source feed: China

> China NMPA product recall for Craniofacial internal fixation system by Synthes GmbH published September 22, 2013. Recall level: . The National Medical Products Administration (NMPA) issued an announcement on September 22, 2013, co

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH recalls internal fixation systems for craniofacial surgery.
- Company Name: Synthes GmbH
- Publication Date: 2013-09-22
- Product Name: Craniofacial internal fixation system
- Recall Reason: A surgeon opened product 04.503.7235, batch number 3373621, and found a label for 449.915S, batch number 3373620, inside the product.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: The National Medical Products Administration (NMPA) issued an announcement on September 22, 2013, concerning a voluntary recall initiated by Synthes GmbH for its Craniofacial Surgery Internal Fixation System (Registration No.: CFDA (Imported) No. 3461735). This action was reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The primary issue identified was a packaging error, specifically the discovery of an incorrect batch label (batch number 3373620) inside a product labeled as batch 3373621 (model 04.503.723S). This recall is an overseas action, impacting regions such as the United Kingdom and Japan, and does not directly involve products distributed within China. However, the product is registered for use in China. In response to this situation, the NMPA has instructed provincial, autonomous region, and municipal food and drug administrations to enhance their oversight and management of similar medical devices. The company's internal report to the State Food and Drug Administration regarding this issue was dated September 2008.

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