FDA (Devices) recall action 81967
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.
Product mix up
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.
Signature Orthopedics is recalling 10 Genius Knee Cemented Tibial Components due to a product mix-up. The recall covers units distributed in Florida, New York, and Tennessee.
Signature Orthopedics is voluntarily recalling three Genius Knee Cemented CR Femoral Components due to a product mix-up. The devices were distributed in Florida, New York, and Tennessee.