FDA (Devices) recall action 63744
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.
The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical 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.
BioHorizons is recalling 1,246 units of Titanium Tack Starter Kits because the provided cleaning instructions may not remove residual contaminants after surgical use.
BioHorizons is recalling 174 AutoTac Delivery Handles because cleaning instructions may not remove residual contaminants after surgical use.