FDA Warns Manufacturer to Correct Misbranded and Adulterated Hip Replacement System
The FDA (U.S. Food and Drug Administration) recently announced that on December 15, 2014, it issued a “Warning Letter” to Signal Medical Corporation after inspections revealed that the company has been manufacturing a misbranded and adulterated hip replacement system in violation of the Federal Food Drug and Cosmetic Act (FDCA). FDA Warning Letter. The hip replacement system is called the “MicroSeal Total Hip Acetabular System” and has been made available across the United States for use in hip replacement surgeries.
According to the FDA, Signal Medical began selling the adulterated device without obtaining the required “premarket approval” or “an approved application for an investigational device exemption.” Signal Medical had submitted a marketing application (commonly referred to as a 510(k)) and obtained approval to market the hip system however, after receiving approval, Signal Medical made “major changes and/or modifications” to the hip system and began marketing the new design without notifying the FDA.
The Warning Letter gave Signal Medical 15 days to correct the violations and explain how it will prevent the same or similar violations from occurring in the future. The FDA warned that “[f]ailure to promptly correct these violations may result in . . . seizure, injunction, and civil money penalties.” We will continue to monitor the developments.
If you or a loved one suffered injuries that you believe were caused by a medical device such as the Signal Medical hip replacement system, contact one of the experienced medical device attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.