FDA (Devices) recall action 84180
The FDA (Devices) publishes a recall like this one as 12 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 12 pages.
The firm discovered a lack of adequate documentation confirming sterility on certain products.
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.
Wright Medical Technology is recalling 42 units of CPS Calcaneal Plates because the firm discovered a lack of adequate documentation confirming sterility.
Wright Medical Technology is recalling 20 units of Swanson Finger Joint #1 implants because documentation confirming sterility was inadequate.
Wright Medical Technology is recalling 77 units of Dart Fire Headed Screws because the firm discovered a lack of adequate documentation confirming sterility.
Wright Medical Technology is recalling 19 units of PRO-STIM 10cc Injectable because adequate documentation confirming sterility was missing.
Wright Medical Technology is recalling 40 units of Ortholoc 3DI locking screws because documentation confirming sterility was inadequate.
Wright Medical Technology is recalling 54 units of Valor Screws because adequate documentation confirming sterility was missing.
Wright Medical Technology is recalling 66 units of sterile headed drill bits because documentation confirming sterility was inadequate.
Wright Medical Technology is recalling 20 Swanson Trapezium Implants because the firm discovered a lack of adequate documentation confirming sterility.
Wright Medical Technology is recalling 30 Swanson Great Toe implants because the firm discovered a lack of adequate documentation confirming sterility.
Wright Medical Technology is recalling 65 units of INBONE STEM, TIBIAL, TOP components because adequate documentation confirming sterility was not found.
Wright Medical Technology is recalling 30 units of Evans Opening Wedge Plates because documentation confirming sterility was inadequate.
Wright Medical Technology is recalling 18 units of Swanson Finger Joint #2 implants because documentation confirming sterility was inadequate.