China NMPA Product Recall - Cannulated Screw System

The National Medical Products Administration (NMPA) announced on May 29, 2025, a voluntary Class II recall initiated by Synthes GmbH, the manufacturer of the Cannulated Screw system. This recall was reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The primary issue prompting this action is a critical misalignment of the center hole found in a specific batch of the Cannulated Screw system, which holds National Medical Device Registration Certificate No. 20163131218. The misalignment could potentially compromise the safety and efficacy of the device during medical procedures, necessitating its removal from the market to prevent patient harm. A Class II recall indicates that the use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Synthes GmbH, in collaboration with Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., is undertaking this recall to ensure compliance with regulatory standards and to safeguard public health. Further details regarding the specific models, specifications, and affected batches are documented in the "Medical Device Recall Event Report Form," an essential document for stakeholders and medical professionals to identify and manage the recalled products effectively. This proactive measure underscores the companies' commitment to product quality and patient safety under the NMPA's regulatory oversight.