China NMPA Product Recall - Manual tools for total hip replacement surgery

Smith & Nephew, Inc., via its agent Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., initiated a voluntary Class III recall of manual tools for total hip replacement surgery. This action, reported to the National Medical Products Administration (NMPA), was prompted by the discovery of incorrect expiration dates printed on the labels of these surgical instruments. The affected product, identified by registration certificate code 国械备20140087, includes specific models like Bone Chisel No. 14, which are used for assembling and implanting orthopedic hip joint components. Although the recall was reported to the NMPA, the documentation indicates that zero affected products were sold in China and that the issue primarily impacts other regions, specifically the USA and Australia. The agent submitted a "Medical Device Recall Event Report Form" to the Provincial Food and Drug Administration on October 30, 2017, detailing the necessary actions to address this labeling discrepancy.