FDA (Devices) recall action 70859
The FDA (Devices) publishes a recall like this one as 19 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 19 pages.
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction.
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
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 151 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.
Wright Medical Technology is recalling 242 units of the Crosscheck Plating System because dimensional specifications are out of range, posing a risk of intraoperative malfunction.
Wright Medical Technology is recalling 92 units of the Crosscheck Plating system because dimensional specifications are out of range, posing a risk of intraoperative malfunction.
Wright Medical Technology is recalling 308 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.
Wright Medical Technology is recalling 172 units of the Crosscheck Plating System because specific dimensions are out of specification, posing a risk of intraoperative malfunction.
Wright Medical Technology is recalling 102 units of the Crosscheck Plating System because specific dimensions are out of specification, posing a risk of intraoperative malfunction.
Wright Medical Technology is recalling 128 units of the Crosscheck Plating System because dimensional specifications are out of range, posing a risk of intraoperative malfunction.
Wright Medical Technology is recalling 372 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.
Wright Medical Technology is recalling 167 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.
Wright Medical Technology is recalling 102 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.
Wright Medical Technology is recalling 138 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.
Wright Medical Technology is recalling 301 units of the Crosscheck Plating System because dimensional specifications are out of range, posing a risk of intraoperative malfunction.
Wright Medical Technology is recalling 52 units of the Crosscheck Plating System because dimensional specifications are out of range, posing a risk of intraoperative malfunction.
Wright Medical Technology is recalling 100 units of Crosscheck Plating Systems because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.
Wright Medical Technology is recalling 148 units of the Crosscheck Plating system because specific dimensions are out of specification, posing a risk of intraoperative malfunction.
Wright Medical Technology is recalling 270 units of the Crosscheck Plating System because specific dimensions are out of specification, posing a risk of intraoperative malfunction.
Wright Medical Technology is recalling 142 units of the Crosscheck Plating system because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.
Wright Medical Technology is recalling 51 units of the Crosscheck Plating System because dimensional specifications are out of range, posing a risk of intraoperative malfunction.
Wright Medical Technology is recalling 233 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.