China NMPA Product Recall - Knee prostheses (brand name: Triathlon), knee revision prostheses (brand name: Triathlon TS)

Howmedica Osteonics Corp., with its distributor Stryker (Beijing) Medical Devices Co., Ltd., initiated a voluntary recall for specific knee prostheses and revision knee prostheses in China, as reported on June 12, 2015, and published by the National Medical Products Administration (NMPA) on July 13, 2015. The affected devices included knee prostheses (Trade Name: Triathlon, Registration Certificate No.: CFDA (I) 20143462912) and revision knee prostheses (Trade Name: Triathlon TS, Registration Certificate No.: CFDA (I) 20143460865). The main issue was incorrect packaging labeling, where labels for product numbers 5531319 and 5537-G-319 erroneously displayed product number 5532-G-511. Operating under the regulatory oversight of China's NMPA, the company confirmed that although the recall was global, no affected products were imported or sold into the Chinese market. Consequently, beyond reporting the labeling discrepancy to the State Food and Drug Administration, no additional corrective actions were undertaken by the company for products within China. The NMPA instructed provincial authorities to strengthen supervision of similar medical devices.