FDA (Devices) recall action 66545
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.
Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.
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 four units of Genesis II tibial base components due to size and side mislabeling.
Smith & Nephew is recalling four units of Genesis II tibial base implants due to packaging errors where size 5 left and size 6 right components were swapped.