While there have been a number of high-profile medical device recalls that have made headlines recently, one such recall seems to have flown under the radar since it was announced earlier this year.
In April, the Food and Drug Administration issued an urgent recall for the Stryker ShapeMatch Cutting Guide used to guide bone markings in knee replacement surgery.
The recall was so severe that the FDA asked all patients who had had surgery in which the guide was used and who were experiencing complications to contact their surgeons immediately.
However, the agency had known about potential serious side effects associated with the medical device much earlier.
In November 2012, the agency e-mailed registered surgeons and imaging centers about software problems and told them to immediately stop performing any procedure that involved the Stryker ShapeMatch Cutting Guides used for the Triathlon Knee System.
When the recall was announced, the FDA said that it had received 44 reports of problems associated with the ShapeMatch, including malfunctions and injuries.
Healthcare providers and patients can report any adverse reactions associated with the product to the FDA. Those who have suffered serious problems may also want to file a ShapeMatch Cutting Guide lawsuit in order to seek compensation.