FDA (Devices) recall action 98376
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.
Impactor handle may be missing cross-pin
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 the Equinoxe Ergo Modular Impactor Handle, model 321-09-05, because the impactor handle may be missing a cross-pin.
Exactech is recalling the Equinoxe Core Instrument Kit, model KIT-311X, because the impactor handle may be missing a cross-pin.