China NMPA Product Recall - VICRYL PLUS Polyglactin 910 Synthetic Absorbable Suture

The National Medical Products Administration (NMPA) announced on January 16, 2023, that Johnson & Johnson + International c/o European Logistics Centre, in collaboration with Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., is initiating a voluntary recall of its VICRYL PLUS Polyglactin 910 Synthetic Absorbable Suture. The recall stems from a specific manufacturing issue involving a single-sided opening of the initial packaging seal on a particular model and batch of the product. This packaging defect raises concerns about the potential compromise of the suture's sterility or integrity, which could affect patient safety. The affected product is identified by Registration Certificate No.: 20163024343. Operating under the NMPA's regulatory framework, this action is classified as a Level III recall, indicating that the use of or exposure to the product is not expected to cause serious adverse health consequences. Johnson & Johnson is undertaking this voluntary recall to address the quality control deficiency. Comprehensive details regarding the specific models, specifications, and affected batches are available in the attached "Medical Device Recall Event Report Form," and the company is responsible for ensuring the complete and safe removal of all impacted products from the market in compliance with NMPA guidelines.