# China NMPA Product Recall - Bone screws

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/59b32fed-fed6-412a-89a8-c79e514fc49a/
Source feed: China

> China NMPA product recall for Bone screws by Synthes GmbH published April 25, 2024. Recall level: Level 3 Recall. On April 25, 2024, the National Medical Products Administration (NMPA) announced a voluntary Class I

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH Voluntary Recall of Bone-Connecting Screws
- Company Name: Synthes GmbH
- Publication Date: 2024-04-25
- Product Name: Bone screws
- Recall Level: Level 3 Recall
- Recall Reason: The model and specification information on the labels of two batches of bone screws were inconsistent with the actual products.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: On April 25, 2024, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Synthes GmbH, a medical device manufacturer. This action was reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The recall specifically concerns bone screws, registered under National Medical Device Registration Certificate No. 20173461994.

The core issue stems from discrepancies identified in two batches of these bone screws. The product label model and specification information were found to be inconsistent with the actual product. Such inconsistencies are critical as they could potentially lead to incorrect product usage or patient safety concerns.

Operating under the NMPA's regulatory framework, a Class III recall signifies that while the use of the affected product is not likely to cause adverse health consequences, corrective action is still necessary to maintain product integrity and labeling accuracy. The manufacturer, Synthes GmbH, is undertaking a voluntary recall of the impacted bone screws to resolve these labeling errors and ensure that all product information precisely matches the physical device.

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. facilitated the reporting of this recall, underscoring their dedication to upholding product quality and patient safety standards as mandated by the NMPA. Additional specifics regarding the affected models and batches are detailed in the accompanying Medical Device Recall Event Report Form.

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