# China NMPA Product Recall - Dynamic locking screw

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/d96d40f5-df63-4cb2-aba4-96211a9b7b8b/
Source feed: China

> China NMPA product recall for Dynamic locking screw by Synthes GmbH published July 17, 2013. Recall level: . Synthes GmbH, working with Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a volun

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH recalls dynamic locking screws.
- Company Name: Synthes GmbH
- Publication Date: 2013-07-17
- Product Name: Dynamic locking screw
- Recall Reason: During the removal of the implant, the distal end of the screw was found to be broken.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: Synthes GmbH, working with Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary recall of its Dynamic Locking Screws, effective July 17, 2013. The recall stemmed from reports of distal screw breakage encountered during the removal of implants, even after successful healing. Specific models affected include 09.213.022S-09.213.070S and 09.223.0325-09.223.0908, particularly DLS 3.7 mm and DLS 5.0 mm screws. The National Medical Products Administration (NMPA) oversees such actions in China. Despite the identified quality concern, the product was not registered for commercial sale in China; only 28 registered samples were imported, and no units were sold to end-users. As a result, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. fulfilled its reporting obligations to the State Food and Drug Administration but was not required to undertake further investigative or corrective actions within China beyond the initial notification, due to the product's unregistered status and lack of commercial distribution.

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