ShapeMatch Cutting Guide Recall Designated Class I By FDA
This past January, the Stryker Corporation announced the recall of ShapeMatch Cutting Guides typically used during knee replacement surgery. The company worried that the products may have been produced in a manner not in line with approved procedural methods or in the parameters laid out in surgical preoperative planning. At the time, surgeons were told that, although they were to bring the items back, meeting with the patient in a manner that went further than routine care was not required. Now, though, the company is explaining that the recall has been designated as Class I by the Food and Drug Administration. This is the most serious form of recall there is. Patients who experience a problem with their ShapeMatch Cutting Guide could find their knee replacements not working as they should.
To learn more about this recall, click here.