FDA (Devices) recall action 89007
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 package contents and package labeling do not match.
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.
Wright Medical Technology is recalling the INBONE Total Ankle System because package contents do not match the package labeling on affected units distributed in Michigan and Pennsylvania.
Wright Medical Technology is recalling INBONE Total Ankle System implants because the package contents and package labeling do not match.