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WARNING LETTER

Rex Implants Inc. MARCS-CMS 676429 —

Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Giuseppe Vercellotti
Recipient Title
President & CEO
Rex Implants Inc.

850 Michigan Ave
Columbus, OH 43215
United States

g.vercellotti@reximplants.com
Issuing Office:
Center for Devices and Radiological Health

United States

WARNING LETTER
CMS#676429

March 12, 2025

Dear Giuseppe Vercellotti:

During an inspection of your firm located in Columbus, OH on December 5, 2023, through December 14, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of the following devices: the REX Mallet; the rexpander devices; and the PiezoImplant REX BL 2.9 implant system that consists of the REX BL 2.9 implant body, and the Straight, Angled, Healing, Provisional Cylinders, and Multi-Unit abutments. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. Specifically, these devices are intended to treat an edentulous condition to restore chewing function.

FDA has reviewed the information collected during the inspection as well as information on your website at www.reximplants.com; last accessed November 23, 2024, and determined that the devices listed above are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The aforementioned devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

1. Your firm currently has a clearance for the Piezoimplant System, a tissue level blade form endosseous dental implant body and associated dental implant abutments under K211872 for the following indications:

The Piezolmplant System is intended for use in dental implant applications for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The prosthetic components are connected to the implants by the corresponding abutments. The Piezolmplant System is intended for delayed loading.

The information on your website, demonstrates that the PiezoImplant REX BL 2.9 implant system is currently being marketed for uses that exceed or otherwise differ from your 510(k) clearance in K211872.

- The Instructions for Use for the PiezoImplant REX BL 2.9 implant system indicate that if there is implant mobility upon placement, the surgeon has the option to place the implant body deeper, whereas the Instructions for the Piezoimplant System, as cleared in K211872, stated that the implant body should be removed if there is mobility upon placement. This change represents a significantly modified risk. See item A.1.5 of the FDA guidance document, “Deciding When to Submit a 510(k) for a Change to an Existing Device.” Placement of the implant body deeper in order to stabilize the implant body implies that the osteotomy has been overprepared – i.e., is too large. The process of placing the implant body deeper is not in line with the standard protocol of splitting the ridge down to the apical aspect of the osteotomy. This change in surgical procedure increases the risk of buccal plate fracture, due to increased bone bending and inferior alveolar nerve damage, leading to permanent nerve damage or sensory loss, if the device is placed too deep in the mandible. Additional concerns include sinus perforation and damage to the maxillary artery, necessitating emergency surgery, if the device is placed too deep in the maxilla. You have not conducted an adequate risk assessment to assess this change.

- As cleared in the K211872 submission, the labeling defined that the minimum buccolingual ridge that the Piezoimplant system can be used in is 3.5mm. The information provided in the K211872 submission did not support an indication for placement of the devices in a ridge less than 3.5mm. However, according to the Instructions for Use for the PiezoImplant REX BL 2.9 implant system, the BL implant bodies are intended for placement in ridges that are greater than or equal to 3mm, which constitutes a major change or modification to its intended use. Specifically, the labeling for the REX Piezoimplant BL device system allows for treatment of ridges that measure 3mm buccolingually. The use of the device system in a narrower ridge is a change in patient population, (i.e., a population with a more severely resorbed ridge). See FDA guidance document, “Deciding When to Submit a 510(k) for a Change to an Existing Device.” This new patient population includes patients with a buccolingual ridge of less than 3.5mm and presents an increased risk of buccal plate fracture, inferior alveolar nerve damage in the mandible due to proximity of this critical structure, and sinus perforation, with possible damage to the maxillary artery in the maxilla. Patients with limited alveolar bone have less bone available for stable implant placement, and if device failure occurs, will require significant revision surgeries through guided bone regeneration in order to regain lost bony support.

- The K211872 clearance described only a tissue level blade-form implant design, with an external hex connection platform, along with abutments compatible with the external hex connection. The PiezoImplant REX BL 2.9 implant system is a bone level design with a different connection platform for attachment of abutment devices, which is a change in technology that could significantly affect the safety or effectiveness of the device. See FDA guidance document, “Deciding When to Submit a 510(k) for a Change to an Existing Device. The modified risks include an increased risk of implant fracture, requiring additional surgery to retrieve damaged implant parts, restoration failure or fracture, buccal plate fracture leading to loss of osseointegration, and permanent nerve damage. However, you have not conducted an adequate risk assessment to assess this change.

2. Based on the evidence obtained from your firm’s website (https://catalog.reximplants.com), you are offering for sale the following devices: the “rexpanders” and “REX Mallet.” The “REX Mallet” is also called an “Implant Placement Device,” or “IPD.” We have reviewed our files and are unable to identify any FDA clearance or approval for the rexpanders and REX Mallet. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), the “rexpanders” and “REX Mallet” are devices because they are intended for use in the mitigation or treatment of disease, i.e., to treat an edentulous condition. Per the Instructions for Use for the Piezoimplant REX BL implant system, and the Instructions for Use for the rexpander devices, the rexpander devices are intended to be used for alveolar ridge splitting including use of force to expand the bone. Per the Instructions for Use for the REX mallet device, this device is intended to exert force in a surgical setting. Therefore, the REX Mallet and rexpanders are devices are used for alveolar ridge splitting, a surgical technique with a significant learning curve to prevent patient harm in the form of buccal plate fracture. Improper use of alveolar ridge splitting can lead to significant patient harm in the form of buccal plate fracture, damage to adjacent teeth, and damage to critical structures such as the inferior alveolar nerve, resulting in the need for revision surgery or permanent nerve damage.

3. Based on evidence obtained from your firm’s website (https://catalog.reximplants.com/products/components-for-digital-workflow) as of April 3, 2024, your firm is marketing titanium bases intended for use with the REX Piezoimplant TL system. The K211872 submission only included abutments that are not intended to be used with a patient-specific top half. The titanium bases are intended to be used with a patient-specific top half that is cemented to the base. The titanium bases introduce a new biocompatibility concern compared to the devices cleared in the K211872 submission. See item C4 of the FDA guidance document, “Deciding When to Submit a 510(k) for a Change to an Existing Device.”

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent via email to Gina Brackett, Establishment Assessment Team (EAT) Assistant Director at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case # 676429” when replying. If you have any questions about the contents of this letter, please contact: Sargum C. Morgan, EAT Compliance Officer at sargum.morgan@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.

Sincerely,
/S/

RDML Sean M. Boyd, MPH, USPHS
Director
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

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