Srg36 I agree with your statement “However, no matter how robust a design is, there is always the potential for unforeseeable risks that were not visible to the manufacturer or the FDA at the time of approval.” Granted its the job of the FDA and the company to extensively test these products but there are also technological limitations to testing. For example, in vivo implants see a lot of recall, this can be due to the fact that mimicking the body’s condition is very difficult. Unless the technology allows for prolonged in vivo performance, there can be a slight certainty on how an implant might behave years form implantation due to varying activities of the body. Medical devices and the technology needed to extensively test them I can say go hand in hand. Even though you can say it is the fault of the FDA and the company for having a defect/recall, testing and research can have its limitations when it comes to new innovative products and the uncertainty of its performance.