China NMPA Product Recall - Knee prostheses, patellar components

Howmedica Osteonics Corp., a manufacturer of medical devices, initiated a voluntary Class II recall of specific batches of knee prostheses and patellar components. The National Medical Products Administration (NMPA) published this information on September 19, 2019. The recall was reported by Stryker (Beijing) Medical Devices Co., Ltd., and stems from a potential issue where the packaging of these medical devices may have been compromised by contamination with water and/or steam. This contamination could affect product sterility or integrity. The affected products include knee prostheses (Registration Certificate No.: 20193132104) and patellar components (Registration Certificate No.: 20183130388). The specific models, specifications, and batch numbers subject to the recall are detailed in the accompanying "Medical Device Recall Event Report Form" attachment, which outlines the required actions for addressing this packaging deficiency.