China NMPA Product Recall - Femoral Head

On June 9, 2021, the National Medical Products Administration (NMPA) publicized a voluntary recall initiated by DePuy International Limited, a medical device manufacturer. The recall specifically concerns certain models and batches of its femoral head products, registered under certificate number 20153461468. The primary issue prompting this Class III recall is a critical discrepancy between the etched model and size information appearing on the product itself and the actual specifications of the device. This labeling inaccuracy could potentially lead to incorrect product identification or use. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. reported this issue to the NMPA, leading to the public announcement. As a required action under the NMPA's oversight, DePuy International Limited is conducting a voluntary recall of the affected femoral heads to address this labeling inconsistency. Detailed information regarding the specific models, specifications, and batch numbers implicated in this recall is available in the "Medical Device Recall Event Report Form." This action underscores the commitment to patient safety and adherence to product integrity standards within the medical device industry.