China NMPA Product Recall - PDS II (polydioxanone) synthetic absorbable suture

The National Medical Products Administration (NMPA) announced on December 16, 2022, a voluntary Class III recall initiated by Ethicon, Inc. This recall pertains to specific models and batches of their PDS II (polydioxanone) synthetic absorbable sutures. The issue, reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., centers on the tensile strength of these sutures, which was found to be lower than the internal control requirements established by the manufacturer. This deviation in strength could potentially impact the intended performance and efficacy of the sutures during medical procedures. Ethicon, Inc. is undertaking this recall to address the quality concern. While no specific inspection dates were provided in the public notice, the regulatory framework of the NMPA is overseeing the process to ensure appropriate actions are taken. Parties affected by this recall are directed to consult the "Medical Device Recall Event Report Form" for precise details regarding the involved product models, specifications, and batch numbers, ensuring adherence to the required actions for product retrieval and management.