FDA (Devices) recall action 84383
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Products were distributed with the incorrect instructions for use.
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.
AAP Implantate Ag is recalling two units of INTEGRA Drill CS 4.5 in Texas due to incorrect instructions for use.
AAP Implantate Ag is recalling 7 units of INTEGRA Drill CS 4.0 in Texas due to incorrect instructions for use.