China NMPA Product Recall - SynMesh Titanium Mesh

Synthes GmbH, a manufacturer whose products are distributed by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary Class III recall of its SynMesh titanium mesh. The recall was prompted by a labeling error affecting specific models and batches of the product, which is identified under Registration Certificate No.: 20163464670. This action was reported on November 30, 2020, under the oversight of the National Medical Products Administration (NMPA) in China. The NMPA serves as the primary regulatory authority governing medical device safety and compliance in the region. The recall requires the company to address the identified labeling inaccuracies to prevent potential misuse or misidentification of the affected SynMesh titanium mesh products. Further details regarding the specific models, specifications, and batch numbers involved in this recall are provided in the "Medical Device Recall Event Report Form" referenced in the NMPA's public notification. This voluntary action underscores the manufacturer's responsibility to maintain accurate product information and adhere to regulatory standards for medical devices.