China NMPA Product Recall - Synthetic absorbable surgical sutures

Johnson & Johnson International c/o European Logistics Centre, in collaboration with Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary Level II recall of specific synthetic absorbable surgical sutures. Announced on August 29, 2023, the recall addresses a critical manufacturing deviation: certain batches of their VICRYL sutures, which are non-antibacterial products, were incorrectly coated with triclosan, an antibacterial agent. This issue represents a significant quality control concern, as the product's intended specifications were not met. The recall is overseen by the National Medical Products Administration (NMPA) and pertains to products registered under National Medical Device Registration Certificate No. 20153023326. The company's immediate action involves the voluntary retrieval of all affected sutures, with comprehensive details on the involved models, specifications, and batch numbers provided in an accompanying recall report. This measure underscores the company's commitment to ensuring product integrity and patient safety while complying with regulatory standards.