China NMPA Product Recall - Arthrex Ankle Plates and Screws Foot and Ankle Locking Plate System

The National Medical Products Administration (NMPA) issued a notice on September 2, 2024, regarding a voluntary Class III recall initiated by Arthrex, Inc. The recall, reported by Arthrex Medical Devices (Shanghai) Co., Ltd., pertains to the Arthrex Foot and Ankle Locking Plate System, specifically Art Plates and Screws (National Medical Device Registration Certificate No. 20243130121). The core issue identified was incorrect anodizing and laser marking on the left and right plates of some product batches. This proactive measure falls under the NMPA's regulatory framework for medical devices. A key detail is that the specific products involved in this recall were not imported into China. Therefore, while the company is taking required actions to recall the affected devices globally, there is no direct impact on the Chinese market. Detailed information on models and batches is available in the Medical Device Report Form. This action underscores the importance of stringent quality control in medical device manufacturing.