Hey DaisyMae,
Have you looked at the DeviceAdvice site here:
http://www.fda.gov/MedicalDevices/D...ts/RecallsCorrectionsAndRemovals/default.htm? It helps clarify this process which is confusing to many (including myself).
My understanding is that anytime you have a correction/removal event you need to determine if it is reportable or not. If it is a class III recall then it does not need to be reported to FDA but must have some internal documentation. You can notify the FDA of any recall event and they will do their own determination of if it needs to be reported (this is optional). In a recent FDA audit I discussed this with the auditor and also found it a bit confusing that you could submit all the information required in a recall report to FDA to determine if you need to submit a recall report (which by then you have in essence already submitted!), but that truly appears to be the process. So, you can do your own determination or you can send a notice to FDA if you are uncertain and they will help you with the determination.
I have created the attached form to help us work through any correction/removal events and have the documentation necessary.
I'm not sure if this answers your question, but hopefully there is something there that helps.