In all likelihood, the mea culpa was related to off-label use, claims made in marketing material and a White Paper. These claims were made outside the scope of their 510(k) clearance. The EnGuard was cleared with limitations as a cover for vessels (Aorta and Vena Cava) after anterior vertebral surgery. It seems like Annie Oakley could use some real help at Replication. Many of the companies with these barriers are having a tough go of getting these products into the marketplace. Obviously, anyone looking to sell these products has to have a surgeon in their territory that loves to perform 360's, and TSB is not talking about aerials. So it seems like the powers to be at Replication have until the this week to respond to the FDA. Good luck and you know what the FDA will say to you, "don't ever let this happen again." A slap on the wrist is better than getting slapped around.