China NMPA Product Recall - Knee joint system component — Tibial liner

This document from the National Medical Products Administration (NMPA) details a voluntary Class III medical device recall initiated by Howmedica Osteonics Corp. The recall, reported by Stryker (Beijing) Medical Devices Co., Ltd., concerns a specific component of a knee joint system: the tibial liner (Medical Device Registration No. 20213130214). The primary reason for this recall is identified as potential product confusion. While the document does not specify inspection dates, the recall information was published on May 22, 2023. Howmedica Osteonics Corp., the manufacturer, has proactively undertaken this action to address the identified issue. Under the oversight of the NMPA, the regulatory body responsible for medical products in China, the company is required to implement the recall of all affected models, specifications, and batch numbers of the tibial liner, as detailed in the accompanying "Medical Device Recall Event Report Form." This action is designed to mitigate any risks associated with the potential confusion and ensure patient safety and product integrity within the regulatory framework.