China NMPA Product Recall - DARCO Plating System for small bone fracture fixation

On April 12, 2022, Wright Medical Technology, Inc. (USA), in collaboration with its subsidiary Wright Medical Devices (Shanghai) Co., Ltd., announced a voluntary recall of its DARCO Plating System, specifically designed for small bone fracture fixation. The National Medical Products Administration (NMPA) recorded this as a Class III recall. The primary issue identified was critical errors in the production and expiration dates for specific models and batches of the affected devices. This action addresses potential risks associated with inaccurate dating information, which could compromise product efficacy or patient safety if devices are used outside their intended lifespan or if their manufacturing details are incorrect. While specific models and batch numbers are detailed in an attached report, the overarching concern relates to fundamental data integrity in product lifecycle management. This recall demonstrates Wright Medical Technology's commitment to regulatory compliance and patient welfare, ensuring the removal of all impacted products to prevent any adverse events stemming from these dating discrepancies.