China NMPA Product Recall - Joint surgery kit

The National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated by Howmedica Osteonics Corp. for specific joint surgery tool kits (Registration Certificate Code: "国械备20171052号"). The recall was reported on October 22, 2019, and publicly issued on November 18, 2019. Stryker (Beijing) Medical Devices Co., Ltd., the product's agent, reported the primary issue as packaging confusion. Specifically, certain batches of 1½" orthopedic positioning pins (6541-4-515) were found to be packaged incorrectly, differing from ½" orthopedic positioning pins (6541-4-575). These tools are utilized during surgery for temporary fixation of tibial plateau templates and femoral measuring devices. Despite the identified packaging discrepancy, zero affected products were sold in China, mitigating direct impact within that market. Howmedica Osteonics Corp. is undertaking corrective actions through this voluntary recall to resolve the packaging inconsistency and ensure product integrity.