China NMPA Product Recall - Non-absorbable polypropylene sutures (trade name: Proline)

Ethicon, LLC, the manufacturer, initiated a voluntary Class III recall of specific batches (model W8121, batch MAJ442) of its non-absorbable polypropylene sutures (trade name: Pro-Ling/Priligy). Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. reported this action on October 23, 2018, with the National Medical Products Administration (NMPA) publishing the notice on November 6, 2018. The recall was prompted by a labeling error discovered by Russian health regulatory authorities during sampling inspections. The primary issue involved an inconsistency between the product name listed on the registration certificate and that on the instructions for use, in addition to some missing label information. Importantly, Ethicon, LLC confirmed that this labeling discrepancy does not affect the product's quality, performance, or patient safety when used as intended. No adverse events related to this issue have been reported. Under the NMPA's regulatory framework, since the affected products were not imported into the Chinese market, no specific corrective actions are required within China. The recall addresses the administrative labeling non-conformity rather than a direct product safety defect.