FDA (Devices) recall action 80126
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.
The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the US with the IFU intended for use outside of the US
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 two Birmingham Hip Resurfacing Femoral Heads because they were distributed in the US with non-US labeling.
Smith & Nephew is recalling six Birmingham Hip Resurfacing Acetabular Cups because they were distributed in the US with international labeling instead of FDA-approved instructions.