FDA (Devices) recall action 66333
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.
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 16 Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.
Smith & Nephew is recalling 45 units of Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.
Smith & Nephew is recalling 8 units of Genesis II mobile bearing articular inserts because the Tyvek lid may not be adequately sealed.
Smith & Nephew is recalling 80 Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.
Smith & Nephew is recalling 46 Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.
Smith & Nephew is recalling 32 Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.