# China NMPA Product Recall - Hollow nail system

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/e05f1c2c-abf3-4af8-823a-864c1dcba7ad/
Source feed: China

> China NMPA product recall for Hollow nail system by Synthes GmbH published November 06, 2018. Recall level: Level 2. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., on behalf of manufacturer Synthes GmbH, init

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH voluntarily recalls its hollow nail system.
- Company Name: Synthes GmbH
- Publication Date: 2018-11-06
- Product Name: Hollow nail system
- Recall Level: Level 2
- Recall Reason: The manufacturer discovered that the thread length indicated on the label of the 3.0mm hollow screw (HCS 03 self-drilling hollow L18/6 TAN gold) did not match the actual thread length inside the packaging. One specific batch of 3.0mm hollow screws, whose label indicated a long-thread screw with a thread length of 6mm, was found to be a short-thread screw with a thread length of 4mm.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., on behalf of manufacturer Synthes GmbH, initiated a voluntary Level 2 recall for a specific batch of its Hollow Nail System. The recall was reported to the National Medical Products Administration (NMPA) on October 11, 2018, with public notification on November 6, 2018. The core issue was an error in product labeling for the 3.0mm hollow nail (Model 04.226.118, Batch L734474). Labels incorrectly indicated a 6mm thread length, describing them as "long-thread screws," when the actual product featured a 4mm thread length, qualifying them as "short-thread screws." This discrepancy in product identification could potentially affect proper surgical application for internal fixation of fractures.

Operating under the NMPA's regulatory framework, the company submitted a Medical Device Recall Event Report Form. However, since the identified batch had not been imported into China, and no units were distributed domestically, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. stated that no further corrective actions, investigations, or reports beyond the initial NMPA notification would be undertaken in China. The primary affected region for product distribution was noted as the USA.

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