China NMPA Product Recall - TriGen InterTAN Hip Fracture Nailing System

On May 6, 2022, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Smith & Nepew, Inc., USA, for its TriGen InterTAN Hip Fracture Nailing System. The recall was reported by Smith & Nepew Medical Products International Trading (Shanghai) Co., Ltd., following the identification of a manufacturing error in a specific model and batch of the product. The affected medical device is registered under certificate number 20143135639. This proactive measure is a required action by the company to address the identified defect. A Class II recall signifies that the use of or exposure to the affected product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. The company's action, under the regulatory framework of the NMPA, aims to ensure patient safety and compliance with quality standards by removing the potentially compromised devices from the market. Detailed information regarding the specific models, specifications, and involved batches can be found in the "Medical Device Recall Event Report Form" referenced in the NMPA's official communication.