# China NMPA Product Recall - Metal intramedullary nail system

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/e81dd9f0-3b02-46c3-8315-72f66d4e5045/
Source feed: China

> China NMPA product recall for Metal intramedullary nail system by Synthes GmbH published February 21, 2023. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) issued a notice on February 21, 2023, concerning

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH is voluntarily recalling its intramedullary nail system.
- Company Name: Synthes GmbH
- Publication Date: 2023-02-21
- Product Name: Metal intramedullary nail system
- Recall Level: Level 3 Recall
- Recall Reason: Issues with discrepancies between product label length and actual length
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: The National Medical Products Administration (NMPA) issued a notice on February 21, 2023, concerning a voluntary Class III recall of the Synthes G Intramedullary Nail System. The recall was initiated by the manufacturer, Synthes GmbH, and reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The primary issue identified is a significant discrepancy between the product's labeled length and its actual physical length for a specific model and batch. This classification indicates that the use of or exposure to the affected product is not likely to cause adverse health consequences. The NMPA, as the regulatory authority, published this information to ensure transparency regarding medical device safety. As a required action, Synthes GmbH is voluntarily withdrawing the affected products from the market to correct the labeling inaccuracy. Comprehensive details regarding the specific models, specifications, and batch numbers involved are provided in an attached "Medical Device Recall Event Report Form," which affected parties should consult for further guidance. This recall highlights the critical importance of accurate product information for medical devices to ensure appropriate use and patient safety.

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