I have worked on another project where it failed because of issues that it was having in the field. Our company acquired the product from another small start up company, and since the product was already 510k cleared and released to the market, my company decided to ramp up production and sell as much of this product, since it was being sold at a premium and was very profitable. That is when all kinds of issues started popping up in the field, with failures being reported. In the meantime we were working on integrating the product into our systems and procedures, to make sure the product conformed to our standards, and as all of these issues were popping up in the field we also were finding many gaps in the DHF and manufacturing processes. We then made the decision to recall the product and after finding out that we really could not fix the issues without a major redesign, we just canceled the project altogether. A couple lessens learned was that companies need to be very vigilant and thorough in their due diligence, and when acquiring a product, don’t immediately ramp up production before fully understanding the production processes and before checking to make sure everything is up to good quality standards.