Recall trends of FDA-cleared shoulder and elbow devices.

초록

The requirements for medical device approvals are based on the classification and the associated risks. Based on the type of approval, there can be a higher risk of recall for orthopedic medical devices. The purpose of this study is to analyze the risk of recall for shoulder/elbow devices. A retrospective review was conducted of publicly available U.S. Food and Drug Administration databases to identify cleared for market and recalled shoulder and elbow devices. Nonorthopedic and unrelated device