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

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class III recall of specific absorbable sutures (VICRYL PLUS) in China, as reported on July 19, 2017, to the National Medical Products Administration (NMPA). This action followed routine market supervision and spot checks, which identified that a batch of the sutures had a diameter slightly exceeding the registered product standard. While Johnson & Johnson confirmed that the products met their internal release standards and posed no reported risk to patient health or surgical outcomes, the recall was undertaken to ensure full compliance with Chinese medical device regulations. The affected products were identified under registration number CFDA (Imported) No. 20123654478 (Revised), with 242 boxes of model VCP311H, specification KBK922, distributed in China. Required actions included notifying all affected customers and obtaining confirmation of receipt. Additionally, all unused products were to be returned to Johnson & Johnson for controlled destruction. No complaints or adverse events related to this issue were reported in China at the time of the recall.