China NMPA Product Recall - Oxinuli Femoral Head

Smith & Nephew Inc., through its subsidiary Smith & Nephew International Trading (Shanghai) Co., Ltd., initiated a voluntary Class III recall of its Oxinuum Femoral Head, as reported to the National Medical Products Administration (NMPA) on April 29, 2021. This regulatory action addresses a manufacturing defect: a processing error affecting specific models and batches of the product. This flaw may lead to a higher than expected eccentricity whitening in the affected femoral heads. The recalled product is identified under Registration Certificate No.: 20163460177. While the full details of the affected models, specifications, and batch numbers are documented in the "Medical Device Recall Event Report Form," the core issue is a quality control lapse during production. The NMPA is overseeing this recall to ensure adherence to medical device safety standards in China. Smith & Nephew's proactive and voluntary recall underscores its commitment to product quality and patient safety, aligning with the NMPA's regulatory framework for managing product-related risks in the medical device industry.