Rex Implants Inc.

Warning LetterOpen

Giuseppe Vercellotti President & CEO Rex Implants Inc. 850 Michigan Ave Columbus , OH 43215 United States g.vercellotti@reximplants.comFEI 3014174860Issued Mar 12, 2025Center for Devices and Radiological Health

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Violations1

Issue DateMar 12, 2025

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Rex Implants Inc.
Location: Giuseppe Vercellotti President & CEO Rex Implants Inc. 850 Michigan Ave Columbus , OH 43215 United States g.vercellotti@reximplants.com
FEI Number: 3014174860
Country: United States
Issue Date: March 12, 2025
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

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.

Rex Implants Inc. FDA Warning Letter, March 12, 2025