China NMPA Product Recall - Non-cemented stem (trade name: PLUS-TS)

Smith & Nephew Surgical Implants (Beijing) Co., Ltd. initiated a Class III voluntary recall of its uncemented handles, branded PLUS-TS (CFDA Approval No. 20143461197), as reported to the National Medical Products Administration (NMPA) on February 7, 2017. The recall was prompted by a manufacturing process issue that resulted in the vacuum plasma spray coating peeling off from specific batches of the product. This defect was discovered within the product packaging prior to use, posing a potential quality concern for the hip prosthesis component. The affected products include various models and specifications, such as A2301 to A2307, with 4450 units sold or imported into China. To address this issue, Smith & Nephew Surgical Implants (Beijing) Co., Ltd. has taken corrective actions by sending written notifications to all affected customers. These notifications requested the return of any unused recalled products to ensure patient safety and product integrity. The recall highlights the importance of robust quality control throughout the manufacturing lifecycle for medical devices. The company's proactive voluntary recall demonstrates adherence to regulatory responsibilities under the NMPA framework.