FDA (Devices) recall action 97275
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.
Inconsistent size terminology and color coding used on labeling
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.
Plastic Trial Head Brown with 7 mm neck length is being recalled because of inconsistent size terminology and colour coding used on the labeling. 17 units are affected.
Prosthesis Head B, 28 mm with 7 mm neck length, is being recalled because of inconsistent size terminology and colour coding used on the labeling. 46 units are affected.