China NMPA Product Recall - Synthetic absorbable surgical sutures

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class III recall for specific batches of synthetic absorbable surgical sutures, as reported by the National Medical Products Administration (NMPA) on August 30, 2016. The recall, stemming from a June 2016 company report, addresses non-compliance with Chinese regulatory labeling requirements. The primary issues identified were discrepancies in the production and expiration dates on the Chinese labels, which did not conform to the original manufacturer's procedures, and an inconsistent registration certificate number compared to the officially approved record. This recall affects 974 boxes of products, specifically models W9560 and W9561, distributed throughout China. The company clarified that these labeling inconsistencies do not pose a direct safety or usage risk to patients but are being addressed to eliminate regulatory non-compliance. Corrective actions include notifying distributors and users to return all unused affected products that are still within their shelf life. These returned sutures will subsequently be destroyed locally, ensuring adherence to regulatory standards and accurate product information in the market.