# China NMPA Product Recall - Locking plate

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/033a17e4-ab3e-458f-92e6-06fb30554cd4/
Source feed: China

> China NMPA product recall for Locking plate by Synthes GmbH published September 18, 2020. Recall level: Level 2 Recall. Synthes GmbH has initiated a voluntary Class II recall of certain locking bone plates, as reported b

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH initiates voluntary recall of locking bone plates
- Company Name: Synthes GmbH
- Publication Date: 2020-09-18
- Product Name: Locking plate
- Recall Level: Level 2 Recall
- Recall Reason: Because certain models or batches of products may have one or more feature dimensions that exceed tolerance ranges, this could lead to locking of the bone plate and bone screws.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: Synthes GmbH has initiated a voluntary Class II recall of certain locking bone plates, as reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The National Medical Products Administration (NMPA) announced this recall on September 18, 2020. The primary issue identified is that specific models and batches of the locking bone plates (Registration Certificate No.: 20183462026) have one or more feature dimensions exceeding their specified tolerance ranges. This dimensional deviation presents a critical concern, as it may lead to locking failures between the bone plate and bone screws, potentially compromising the integrity and stability of surgical implants. This action reflects the company's commitment to product quality under the regulatory framework of the NMPA, prioritizing patient safety by removing potentially defective devices from the market. Detailed information on affected products is available in the 

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