FDA (Devices) recall action 75989
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
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.
Exactech, Inc. is recalling 12 polyethylene acetabular liners because they were labeled with incorrect Global Trade Item Numbers (GTINs).
Exactech is recalling 98 Alteon Neck Preserving Stems because they were labeled with incorrect Global Trade Item Numbers (GTINs) that identify them as different devices.
Exactech is recalling 79 Novation Cemented Plus Femoral Stems because they were labeled with incorrect Global Trade Item Numbers (GTINs).