FDA (Devices) recall action 83942
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.
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.
Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the tensioners inoperable.
Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the disposable tensioners inoperable.
Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the disposable tensioners inoperable.
Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the disposable tensioners inoperable.
Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the disposable tensioners inoperable.