# China NMPA Product Recall - Intramedullary Nailing System

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/9cfc9fec-c0c4-489f-aebe-b7ec38e20824/
Source feed: China

> China NMPA product recall for Intramedullary Nailing System by Synthes GmbH published November 07, 2025. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) published a notice on November 7, 2025, concerni

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH is voluntarily recalling its Intramedullary Nailing System.
- Company Name: Synthes GmbH
- Publication Date: 2025-11-07
- Product Name: Intramedullary Nailing System
- Recall Level: Level 2 Recall
- Recall Reason: The screw lengths of both batches of products were correctly etched on the screw body, but the length markings on the outer packaging were incorrect.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: The National Medical Products Administration (NMPA) published a notice on November 7, 2025, concerning a voluntary Level II recall initiated by Synthes GmbH. This action, reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., addresses an issue with Synthes GmbH's Intramedullary Nailing System, which holds National Medical Device Registration Certificate 20193131564. The primary concern involved incorrect screw length markings on the outer packaging of two specific product batches. This labeling error prompted the manufacturer to take corrective action globally. Under the regulatory oversight of the NMPA, Synthes GmbH submitted a "Medical Device Recall Events Report" detailing the affected products. Notably, the NMPA confirmed that no products from the impacted batches were imported into China, ensuring the Chinese market is not affected by this recall event. This voluntary recall demonstrates the company's adherence to medical device safety standards and regulatory protocols.

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