China NMPA Product Recall - Locking Screws

On January 20, 2020, the National Medical Products Administration (NMPA) in China announced a Class III voluntary recall initiated by Synthes GmbH. This recall was reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The affected products are specific batches of Locking Screws (Registration Certificate No.: 20173466154).

The primary issue prompting this action is a packaging defect where the inner cap, which holds the screw and its retainer, may inadvertently remain inside the outer tube upon opening the product's packaging. This defect could potentially impede access to the product or affect its sterility or integrity prior to use.

Operating under the NMPA's regulatory framework for medical device recalls, Synthes GmbH is undertaking this voluntary action to address the identified product issue. Detailed information regarding the specific models, specifications, and affected batch numbers is available in the "Medical Device Recall List." The required action for the company is to execute this Class III recall, ensuring that affected products are identified and removed from circulation, thereby maintaining patient safety and product quality standards.