FDA (Devices) recall action 71985
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
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 5,987 units of the Birmingham Hip Resurfacing Femoral Head due to revision rates higher than established benchmarks.
Smith & Nephew is recalling Birmingham Hip Resurfacing Dysplasia Cups because the system showed higher revision rates than established benchmarks.
Smith & Nephew is recalling specific Birmingham Hip Resurfacing Acetabular Cups because the system's revision rates were higher than established benchmarks.