FDA (Devices) recall action 89495
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.
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
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.
Collagen Matrix is recalling 68 units of DuraMatrix-Onlay Collagen Dura Substitute Membrane due to unsealed outer packaging that may compromise product sterility and increase infection risk.
Collagen Matrix is recalling RESODURA matrix onlay dural substitutes due to outer packaging that is not properly sealed, potentially compromising sterility and creating a risk of infection.