China NMPA Product Recall - Mini universal locking plate system

The National Medical Products Administration (NMPA) announced a voluntary recall initiated by Smith & Nephew, Inc., USA, concerning its Mini Universal Locking Bone Plate System. This recall, formally reported by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., was officially published on December 28, 2023. The central reason for this Class III recall is the discovery of incorrect labeling on a portion of the affected products. This critical issue, pertaining to a medical device registered under National Medical Device Registration Certificate No. 20213130368, requires immediate action to prevent potential patient safety concerns stemming from misidentification or incorrect usage information. In response to this violation, Smith & Nephew, Inc. is undertaking a comprehensive voluntary recall of the specified bone plate system. This measure is crucial for correcting the identified labeling discrepancies and upholding the stringent regulatory standards set forth by the NMPA. Details concerning the specific affected product models, specifications, and batch numbers are comprehensively outlined in an accompanying "Medical Device Recall Event Report Form," submitted by the company's Shanghai affiliate. This proactive recall demonstrates the company's dedication to maintaining product integrity and adhering to regulatory requirements within the medical device industry.