China NMPA Product Recall - Joint surgical tools

On August 29, 2016, the National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated by Howmedica Osteonics Corp. for certain joint surgical tools (Registration No.: CFDA (Imported) No. 20131104042). Stryker (Beijing) Medical Devices Co., Ltd. served as the responsible unit in China for managing the recall.The recall stemmed from four reported incidents of component separation in the Scorpio patellar assembly tools. A subsequent investigation by Howmedica Osteonics Corp. determined that the press-fit parameters between the bone pin and the clamping sub-component did not meet established specifications. Fortunately, the company confirmed that no adverse patient consequences had been reported in connection with these defects.As a corrective action, Howmedica Osteonics Corp. initiated a voluntary recall to retrieve all affected units. In China, 55 units of the identified joint surgical instruments were imported and sold, and all were successfully returned to the factory, ensuring product safety and compliance with regulatory standards.