FDA (Devices) recall action 96694
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.
Inadequate weld that can potentially cause the product to disassemble.
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 CODMAN Disposable Perforators (14mm) due to inadequate welds that could cause disassembly during use. The affected devices have been distributed worldwide.
Integra LifeSciences is recalling CODMAN Craniotomy Kits due to inadequate welds that may cause the product to disassemble. The defect affects 1,840 units distributed worldwide.