China NMPA Product Recall - Interbody fusion cages

Synthes GmbH, the manufacturer, has initiated a voluntary Class III recall of its interbody fusion devices, specifically Cages (National Medical Device Registration No. 20153132585). This action, reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., was published by the National Medical Products Administration (NMPA) on April 3, 2024. The recall was prompted by the discovery of incorrect expiration date markings on two specific product batches. The primary issue identified was a labeling error concerning the expiration dates, necessitating the removal of these devices from the market to ensure patient safety and compliance with regulatory standards. This recall falls under the regulatory oversight of the NMPA, which categorizes recalls based on the potential health risk. The required action involves the systematic retrieval of the mislabeled interbody fusion devices from distribution and use. Further details regarding the specific models, specifications, and batch numbers are provided in the accompanying Medical Device Recall Event Report Form.