China NMPA Product Recall - Polyester non-absorbable sutures

Ethicon, LLC, in conjunction with its agent, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary Class II recall of specific batches of non-absorbable polyester sutures. This action, reported on May 13, 2019, and published by the National Medical Products Administration (NMPA) on May 23, 2019, was prompted by the discovery of a potentially high endotoxin content in the raw materials used to manufacture the affected products. These sutures, registered under certificate no. 20152652256, are indicated for general soft tissue grafting and ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures. The recall affects specific models and batches, including X865W33, X425H, and PBQ797 (batch PBQ426), and impacts regions such as Australia, Canada, and the USA. The required action involves the voluntary recall of these identified products, with no additional corrective actions specified for units not imported into China.