China NMPA Product Recall - Interlocking intramedullary nail system

The National Medical Products Administration (NMPA) published a notice on August 4, 2023, detailing a voluntary Level II recall initiated by Smith & Nephew, Inc. This recall involves certain batches of their interlocking intramedullary nail systems. The issue, reported by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., stems from identified packaging errors affecting some products. These medical devices are registered under National Medical Device Registration Certificate No. 2020. A Level II classification indicates that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. The company's required action involves retrieving the affected products from the market. The NMPA explicitly noted that this specific recall "does not affect China," implying the problematic batches were not distributed within the Chinese market. Further details on specific models, specifications, and batch numbers are provided in an attached Medical Device Recall Event Report Form.