Dealing with recalled components.

Abstract

It is often difficult for orthopedic surgeons to react to a situation where a particular implant that they have been using for many years is suddenly recalled from the market by either the manufacturer or the United States Food and Drug Administration. This report briefly summarizes some of the issues that may arise when such a circumstance occurs. We briefly outline what an implant recall is, what measures the orthopedic surgeon should take when an implant is permanently recalled, what litigation issues may arise, and describe the resources available to the orthopedic surgeon for the evaluation of these patients. It is important to understand that the manufacturer and the insurance companies often bear the burden of the financial loss, although the anguish, time loss for patients, and the effect on clinical practice are issues which are largely inevitable. Nevertheless, it is essential for the orthopedic community to be aware and be prepared for these unlikely situations should they occur, so that we will remain the patient's best advocate at all times.