FDA (Devices) recall action 65370
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.
One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner.
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 specific batches of R3 XLPE acetabular liners because some 60 mm and 62 mm units may be mislabeled with incorrect size markings.
Smith & Nephew is recalling 53 units of R3 XLPE acetabular liners because some 60 mm and 62 mm liners may be laser etched and packaged with incorrect size labels.