China NMPA Product Recall - Hip joint surgical instruments

Smith & Nephew Orthopaedics AG, supported by its agent Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., initiated a Class III voluntary recall for specific hip surgery instruments. This action was officially reported to the National Medical Products Administration (NMPA) on January 30, 2019, under the regulatory framework governing medical devices. The recall stems from a critical manufacturing error: the pin intended to secure the spring mechanism within the instrument was not properly installed and poses a risk of disintegration. This defect could compromise the functionality and safety of the hip joint surgical instruments, which are vital for surgical procedures. Affected models include the 75004613 Double-Off Handle (Right), identified by specific codes. The company's required action is a voluntary product recall to mitigate this safety concern. Crucially, the detailed Medical Device Recall Event Report Form indicates that zero units of the affected product batches were distributed or sold within China. Consequently, while a serious manufacturing issue prompted the global recall, this particular corrective action does not impact the Chinese market directly, as stated in the recall documentation.