China NMPA Product Recall - Absorbable surgical suture STRATAFIX Spiral PDS Plus Knotless Tissue Control Device (National Medical Device Registration Certificate No. 20213020210)

The National Medical Products Administration (NMPA) has overseen a Class II voluntary recall initiated by Ethicon LLC, as reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. This action concerns specific batches of absorbable surgical sutures, specifically the STRATAFIX Spiral PDS Plus Knotless Tissue Control Device (NMPA Registration Certificate No. 20213020210). The primary issue leading to the recall is the failure of these products to meet Johnson & Johnson's internal quality requirements. The recall document, published on August 29, 2025, clarifies that the affected products were not imported, suggesting local manufacturing or distribution within China. A Class II recall indicates that the use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. Ethicon LLC is undertaking this voluntary recall to ensure adherence to product safety and quality standards, with detailed product information available in the "Medical Device Recall Event Report Form" under the NMPA's regulatory framework. This emphasizes the continuous efforts to maintain the safety and efficacy of medical devices within the Chinese market.