FDA (Devices) recall action 69471
The FDA (Devices) publishes a recall like this one as 28 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 28 pages.
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Instrumed International is withdrawing Hudson cerebellar extensions because they were not marketed before September 26, 1976, and do not meet FDA pre-amendment requirements.
Instrumed International is withdrawing 13 manual Bunnell cranial drills because the company did not market them before 1976, failing FDA pre-amendment requirements.
Instrumed International is withdrawing Hudson braces from the market because the devices do not meet FDA requirements for pre-amendment status.