Hi Pat,
Just a clarification on "voluntary" and "recall" actions.
If a company has a product problem and is aware of it, they will contact the FDA to discuss actions. If the problem is not a function of device failure through poor design but rather an issue of wrong application for a certain patient set, the company will voluntarily withdraw the product from the field/shelves. ALL product that is placed in the field but then removed for whatever reason and sent back to the company is classified by the FDA. That is to include items that are in the representatives trunk. There is a #1, #2, #3 classification of recall. #1 can result in serious injury or death. #2 can result in injury or adverse reaction of a serious nature. #3 has little likelihood of injury or adverse consequences.
The action by S&N will more than likely be classified as Class 3 recall.
If product is not returned but rather clinical advice is given such as further defining implant technique, this would simply be a "notification".
Companies cannot change a thing procedurally from manufacturing, to instructions for use by physicians, to removal of product from the field. If there is to be any change from what was originally submitted to the FDA for approval for general use, the FDA has to be notified and render their approval or denial.
If S&N would have advised physicians to only set the acetabular cup to say an angle of >30 degrees but less than 50, and a minimum of 100, 200, 300, or some # of implants, it would have been a notification and qualified doctors would still be implanting the smaller sizes today.
I believe that with the small number of HRA's being done today, S&N did not want to alienate the less qualified surgeons by officially ruling them out. That's bad politically. Had they done so and an inexperienced doctor took it upon himself to implant and not heed the advice, if there was a bad outcome it would fall on the doctor if it ever went to court. After all, he was warned. Companies don't want to play doctor but they do want to minimize their risk and exposure to litigation. S&N took the easy way out politically and financially.
The name of the game is CYA.