FDA (Devices) recall action 80843
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 Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.
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.
Zimmer Biomet is recalling 52 Gentle Thread PLGA Full Thread Interference Screws because they were commingled with a different size.
Zimmer Biomet is recalling 52 Gentle Thread PLGA Round Head Interference Screws because they were commingled with a different screw size.