What? The FDA issues safety warning for STAR Ankle after 23 years of clinical history.

The STAR Ankle has early poly fracture issues, so the FDA issued a warning (scrolll down for FDA statement).
How does this happen?
I worked for a device company that tried to acquire the STAR Ankle in 2005. I learned that the STAR was a very dated design. Ultimately, Small Bones Innovations acquired the ankle, then Stryker acquired SBI.
Dr. Hakon Kofoed in collaboration with LINK AG designed the implant back in 1981 as a fixed bearing version. The "modern" STAR Ankle (generation 4) was designed in 1998. There are 23 years of clinical results and counting for the new STAR Ankle, and 40...