China NMPA Product Recall - V40 Heads Hip Prostheses

On December 30, 2021, the National Medical Products Administration (NMPA) published details regarding a voluntary Class III recall initiated by Howmedica Osteonics Corp. This recall specifically targets certain models and batches of the company's V40 Hip Prostheses, identified under Registration Certificate No.: 20163130078. The manufacturer's action was formally reported to the NMPA by Stryker (Beijing) Medical Devices Co., Ltd.

The core issue prompting this recall involves a potential defect in the sealed packaging of the hip prostheses. It has been observed that the white Tyvek paper cap on the sealed packaging may detach. Such a breach in packaging integrity could potentially compromise the sterility or safe handling of the medical devices, thereby presenting a potential risk to patient safety if the affected products are used.

Operating under the regulatory guidance of the NMPA, Howmedica Osteonics Corp. has undertaken this proactive measure to remove the impacted devices from the market. A Class III recall signifies that there is a low probability that the use of, or exposure to, the violative product will cause adverse health consequences. The company is responsible for managing the recall process, which includes identifying and retrieving all affected units. Comprehensive details, including specific models, specifications, and batch numbers involved in this recall, are provided in the accompanying "Medical Device Recall Event Report Form".