China NMPA Product Recall - Hip prosthesis

The National Medical Products Administration (NMPA) issued a notice on June 13, 2017, concerning a voluntary Class III recall of hip prostheses manufactured by Smith & Nephew, Inc. The recall was reported to the NMPA by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. on May 15, 2017. The central issue identified was a critical packaging error: the outer English label of certain hip prostheses incorrectly specified a "28mm Diameter Head with +4mm offset" (model 71302804), while the actual product inside was a "32mm Diameter Head with a +0mm offset" (model 71303200). This mislabeling could lead to the incorrect product being used. While the recall was initiated under the NMPA's regulatory oversight for medical devices (Registration Certificate No. 20153463804), the report explicitly states that no affected products were sold or distributed in China. The recall's impact was confined to other international regions, specifically Canada and Singapore. Smith & Nephew, Inc. undertook this voluntary corrective action to address the packaging discrepancy and uphold product integrity and patient safety standards.