This is an interesting topic for discussion! I agree with Dr. Simon that labeling or putting a warning on the package is not a direct way of mitigating risk. There are Instructions for use, also known as IFUs, which surgeons use as a guide for the surgery. In the real world, I don’t think this happens as the surgeon must be already trained to the procedure. In my current company, I am working on a project for obsoleting the paper IFUs and updating the labels to have the online (link) IFU reference. In my opinion, there should be tighter controls at final inspection of the product before shipping to the customer. Also, in the OR, the surgeon and the team must be trained to the procedure and the appropriate risk associated with the device prior to the operation. Not to mention, there are some important symbols on the labels that are critical for surgeon to know, such as the if the pack is sterile or not. However, identifying precautions on the labels to mitigate the risk should not be the first resort.