China NMPA Product Recall - Hip prosthesis

Smith & Nephew, Inc., in cooperation with Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., initiated a voluntary Class III recall of certain hip prostheses. This action was reported to the National Medical Products Administration (NMPA) on May 15, 2017, with public notification on June 26, 2017. The core issue involved incorrect product packaging where the outer English label specified model 71302804 (28mm Diameter Head with +4mm offset), but the actual product inside was model 71303200 (32mm Diameter Head with a +0mm offset). This labeling discrepancy resulted in a mismatch between the indicated and actual device. Operating within the NMPA's regulatory framework, companies are obligated to report such product anomalies and implement necessary corrective measures. Although initiated by Smith & Nephew, Inc. and reported via its Shanghai agent, this specific recall primarily impacted distribution in Canada and Singapore, with the document explicitly stating it did not affect sales within China. The required action was the voluntary removal of these mislabeled hip prostheses from the affected international markets to mitigate potential risks associated with incorrect device implantation.