China NMPA Product Recall - Debridement water jet system

Smith & Nephew Medical Ltd, through its agent Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., initiated a voluntary Class III recall of its debridement waterjet system (National Medical Device Registration Certificate 20173211138). The National Medical Products Administration (NMPA) publicly reported this on September 13, 2017, following a recall event report dated August 2, 2017. The primary issue was a production process problem that resulted in the affected debridement waterjet systems lacking the required CE marking upon shipment. This non-compliance with the critical European conformity standard prompted the manufacturer's corrective action. The recall specifically targeted products shipped to Italy and Norway, encompassing models 66800039 Control Console, KWHJ160001, KWHH160027, and KWHH160028. Importantly, the recall report explicitly stated that this action "does not affect China," with zero sales quantity of the affected products reported within China. The required action was a voluntary recall to address the absence of CE marking on specified batches, ensuring regulatory compliance in the affected regions.