FDA (Devices) recall action 97623
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.
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
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.
Integra LifeSciences is recalling 5,109 CODMAN Disposable Perforators, 9mm, extending an existing 14 mm recall for inadequate welds. The FDA has classified it Class I.
Integra LifeSciences is recalling 16,251 CODMAN Disposable Perforators, 11mm, extending an existing 14 mm recall for inadequate welds. The FDA has classified it Class I.