FDA (Devices) recall action 95494
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.
Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
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 a knee prosthesis component after discovering some packages contained a different implant than labeled. No illnesses or injuries have been reported.
Smith & Nephew recalled a knee prosthesis component after a complaint indicated the package contained the wrong size and type of implant instead of what was labeled. This product substitution could result in incorrect implant during surgery.