China NMPA Product Recall - Centralizer

Smith & Nephew, Inc. initiated a voluntary Class III recall of its Centralizer device, as reported by its subsidiary, Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., on September 18, 2021. The recall stems from a critical product issue: specific models and batches of the Centralizer device were found to be unusable due to material deformation.

This action was taken under the oversight of the National Medical Products Administration (NMPA) in China, which published the recall information with index number JGXX-2021-10500. The regulatory framework requires companies to report such events, and Smith & Nephew's voluntary recall demonstrates adherence to these guidelines. The company has submitted a "Medical Device Recall Event Report" detailing the affected product models, specifications, and batches.

While the provided document does not specify inspection dates, the recall itself highlights the importance of product quality and safety monitoring. The required action for Smith & Nephew, Inc. is the comprehensive management and execution of this Class III recall, ensuring affected devices are removed from the market to prevent potential patient harm. This proactive measure underscores the company's commitment to patient safety and compliance with medical device regulations.