FDA (Devices) recall action 89454
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.
May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
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.
DePuy Orthopaedics is recalling ATTUNE Revision knee implant components due to possible adhesive residue on the surface. If undetected before surgery, the residue may cause soft tissue irritation or infection.
DePuy Orthopaedics is recalling 3 units of ATTUNE REVISION DISTAL FEMORAL AUGMENT due to adhesive residue that could cause tissue irritation or infection if not detected before surgery.