China NMPA Product Recall - UroLift System for transurethral implantation of prostate staples

NeoTract, Inc., through its distributor Telefel Medical Devices Trading (Shanghai) Co., Ltd., has initiated a voluntary Class II recall of its UroLift Transurethral Prostate Staple System (Registration Certificate No.: 20223130205). The recall was publicly announced on August 10, 2022, by the National Medical Products Administration (NMPA). This action was taken due to a specific product model and batch experiencing a critical issue where the implant may not be successfully released into the body in a single attempt during the procedure. The manufacturer, NeoTract, Inc., is responsible for the recall. Further details regarding the affected product models, specifications, and batch numbers are available in the accompanying "Medical Event Report Form" and "Enterprise Recall Report Form" attachments. The NMPA, as the hosting regulatory body, oversees this medical device recall event, ensuring compliance with established medical device regulations and patient safety standards.