FDA (Devices) recall action 71344
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.
Incidence of breakage is higher than expected.
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.
Vilex, Inc. is recalling 4 units of FUZE 10.0 mm x 250 mm ankle arthrodesis screws due to a higher-than-expected incidence of breakage.
Vilex, Inc. is recalling 13 units of FUZE 10.0 mm x 150 mm ankle arthrodesis screws because the incidence of breakage is higher than expected.
Vilex, Inc. is recalling FUZE 10.0 mm x 200 mm ankle arthrodesis screws because the incidence of breakage is higher than expected.