Overview of Illinois DePuy ASR Hip Replacement System Recall and Lawsuits
In August 2010, the Federal Drug Administration (FDA) posted a letter it sent to a medical device manufacturer regarding the safety of its metal hip implants. The letter informed the medical device manufacturer that the FDA had become aware that it had not obtained marketing approval before releasing its metal-on-metal hip implant device for sale and that the company should stop marketing this device immediately.
The medical device manufacturer, DePuy Orthopaedics, Inc., had not received FDA approval for its TruMatch™ Personalized Solutions System prior to releasing it for sale. Therefore, the FDA was warning the medical device manufacturer that it needed to cease production of this product while it went through the proper channels of obtaining the FDA's approval.
In addition, while DePuy had been cleared by the FDA to market its Corail® Hip System, which was intended to be used for a total hip arthroplasty. However, DePuy had made several changes to its Corail Hip System that were not approved or tested by the FDA and therefore could not legally be marketed or used.
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