FDA (Devices) recall action 64477
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.
Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment
Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment,
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.
Keystone Dental Inc is recalling 22 units of Genesis Straight Esthetic abutments that were mislabeled with incorrect dimensions.
Keystone Dental Inc is recalling 35 units of Genesis Straight Esthetic abutments because they were mislabeled as 4.0 mm 1 mm cuff units when they are actually 5.0 mm 3 mm cuff units.