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Rex Implants Inc. manufactured three implant device systems (REX Mallet, rexpander devices, and PiezoImplant REX BL 2.9 implant system) intended to restore chewing function in edentulous patients without obtaining either an approved Premarket Approval (PMA) application or an Investigational Device Exemption (IDE), rendering the devices adulterated under federal law. The company also failed to submit the required 510(k) notification before introducing these devices into commercial distribution, resulting in misbranding violations. These violations were identified during an FDA inspection conducted December 5-14, 2023, at the company's Columbus, Ohio facility.