China NMPA Product Recall - Absorbable sutures (product: VICRYL FLOS)

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class III recall of its Absorbable Sutures (VICRYL PLUS), specifically model VCP311H/KBK922, affecting 242 boxes in China. The recall, reported on May 27, 2017, and published by the National Medical Products Administration (NMPA) on July 18, 2017, stemmed from market supervision and spot checks. These checks revealed that the suture diameter of the affected batch was slightly coarser than the registered product standards. While the manufacturer, Ethicon, confirmed that the products were released according to its standards and posed no risk to patient health or surgical procedures, and no adverse events or complaints were reported, the company decided to proceed with the recall to ensure full compliance with Chinese regulations. As part of the corrective actions, Johnson & Johnson required customers to be notified and provide confirmation receipts. Additionally, all unused affected products were to be returned to Johnson & Johnson for unified destruction. This proactive measure underlines the company's commitment to regulatory adherence in the Chinese market.