# China NMPA Product Recall - Cranio-Maxillofacial System

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/db212a19-ed59-4dfb-a22e-1a591b1a5b55/
Source feed: China

> China NMPA product recall for Cranio-Maxillofacial System by Synthes GmbH published November 07, 2025. Recall level: Level 2 Recall. On November 7, 2025, the National Medical Products Administration (NMPA) publicized a voluntary Clas

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH is voluntarily recalling the Cranio-Maxillofacial System, an internal fixation system for craniomaxillofacial surgery.
- Company Name: Synthes GmbH
- Publication Date: 2025-11-07
- Product Name: Cranio-Maxillofacial System
- Recall Level: Level 2 Recall
- Recall Reason: The screws inside the packaging of two batches of products did not match the label information, but the color of the screw clips matched.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: On November 7, 2025, the National Medical Products Administration (NMPA) publicized a voluntary Class II recall concerning the Cranio-Maxillofacial System, manufactured by Synthes GmbH and reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. This medical device, registered under certificate No. 20183131989, was subject to recall due to a critical packaging discrepancy. Specifically, two batches of the product were found to contain screws inside their packaging that did not match the information displayed on the corresponding labels. While the color of the screw clips was consistent with expectations, the incorrect labeling of the screws themselves posed a significant issue regarding product identification and potential use. This voluntary recall by Synthes GmbH underscores the importance of stringent quality control and accurate product information for medical devices. The action aims to mitigate any potential risks associated with mislabeled components and ensure that healthcare professionals receive devices that precisely match their specifications. Further details regarding the affected models, specifications, and batch numbers are documented in the official "Medical Device Recall Event Report Form" available through the NMPA. This measure reflects the manufacturer's commitment to regulatory compliance and patient safety under the NMPA's oversight.

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