China NMPA Product Recall - Dynamic locking screw

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.