FDA (Devices) recall action 95178
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.
Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
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.
Smith & Nephew is recalling Rotation Medical Tendon Staples because packaging defects may compromise sterility. The recall affects 6,465 units distributed worldwide.
Smith & Nephew is recalling 2,961 units of ROTATION MEDICAL TENDON STAPLES due to improper outer foil pouch sealing that may compromise product sterility. No injuries have been reported.