FDA (Devices) recall action 86590
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.
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
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 is recalling 12 Equinoxe Platform Fracture Stems because they may be incorrectly laser marked as right stems when they are left stems.
Exactech is recalling 25 Equinoxe Platform Fracture Stems because they may be incorrectly laser marked as right stems instead of left stems.