China NMPA Product Recall - Knee joint system component — tibial pad

Howmedica Osteonics Corp., a medical device manufacturer, has initiated a voluntary Class III recall of its knee joint system component, the tibial liner. This action was reported by Stryker (Beijing) Medical Devices Co., Ltd. and publicly announced by the National Medical Products Administration (NMPA) on April 3, 2024. The primary concern prompting this recall is the potential compromise of the product's sterile blister packaging, which could lead to non-sterility of the device. Ensuring the sterility of implantable medical devices is critical for patient safety and to prevent potential complications like infection. The affected product is registered under National Medical Device Registration Certificate No. 20213130214. While the document does not specify inspection dates, the NMPA is the regulatory authority overseeing this recall within China. Howmedica Osteonics Corp. is required to undertake comprehensive actions to identify and retrieve all affected units of the tibial liner, with further details provided in the "Medical Device Recall Event Report Form".