FDA WARNING_LETTER - Rex Implants Inc. - December 14, 2023

On March 12, 2025, the FDA issued a Warning Letter to Giuseppe Vercellotti following an inspection from December 5-14, 2023, in Columbus, OH. The firm manufactures the REX Mallet, rexpander devices, and the PiezoImplant REX BL 2.9 implant system. These devices, intended for treating edentulous conditions, were found to be adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) for failure to submit a 510(k) premarket notification.

Specific violations include marketing the PiezoImplant REX BL 2.9 implant system for uses exceeding its K211872 510(k) clearance. Changes include allowing deeper implant placement for mobility (increasing risks of buccal plate fracture, nerve damage, sinus perforation, and maxillary artery damage) and use in narrower ridges (3mm vs. 3.5mm minimum, increasing risks for patients with severely resorbed ridges). The PiezoImplant REX BL 2.9 also features a bone level design with a different connection platform, a significant technological change not adequately assessed for risks like implant fracture or nerve damage.

Additionally, the firm is marketing