FDA (Devices) recall action 84673
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.
Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.
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.
Wright Medical Technology is recalling 39 EVOLVE Modular Radial Heads because the product size inside the package does not match the label or laser marking.
Wright Medical Technology is recalling two lots of EVOLVE Modular Radial Heads because the product size in the package may be incorrect. Both labels and laser markings are wrong.