FDA (Devices) recall action 98516
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.
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
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.
Orthalign is recalling one lot of the Trimax Pegged Drill Plate sizes 1-5 for the Lantern Knee System because plates manufactured out of specification can result in a bone cut in excess of 0.0800 inches.
Orthalign is recalling one lot of the Trimax Pegged Drill Plate for the Lantern Knee System because plates manufactured out of specification can result in a bone cut in excess of 0.0800 inches.