ABSTRACT
Medical device recalls can cost billions. The number of medical device products affected by recalls hit an eight-quarter high in the second quarter of 2012, exceeding 100 million units. Perhaps most striking is the fact that of the 140 medical device companies affected by recalls in the 90-day period in that quarter, one third faced multiple recalls. More than
10 million units were affected. This is a reminder that recalls can happen to any company-especially as more and more companies turn to outsourcing [1]. A division of a highly reputable company paid over $4 billion just to settle 8,000 lawsuits related to a recalled hip joint device that caused severe pain and injury to patients due to generation of metallic particles. In addition, the company paid the surgical expenses of those affected.
