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Restor3D

Also registered as Restor3d, Inc.

United Statesfrom the FDA registration address FDA FEI 3014833750

Devices
3,204
Registrations
FDA
FDA recalls
63 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

Catalogue3,204

Newest first, rows 1-50 of 3,204

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Rows 1-50 of 3,204

Showing 1-50 of 3,204

Company details

FDA FEI number
3014833750
Address
4001 NC Hwy 54, Suite 2160, Durham, NC, 27709

FDA recalls6

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 3
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 3

  • 2026

    • 4 Sep 2026 Z-0264-2027 Not yet classified Ongoing Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization. Distribution: U.S. Nationwide distribution in the states of FL, IL, NC, PA, SC, and TX. Submission number: K201393
    • 27 Jul 2026 Z-3178-2026 Class II Ongoing Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migration, or need for revision surgery. Distribution: US Nationwide distribution in the states of FL, CO. Submission number: K223326
    • 30 Jun 2026 Z-2987-2026 Class II Ongoing Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws. Distribution: U.S. Nationwide distribution in the state of Texas. Submission number: K243643

  • 2022

    • 30 Mar 2022 Z-1026-2022 Class II Terminated Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium. Distribution: US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
    • 30 Mar 2022 Z-1027-2022 Class II Terminated During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots. Distribution: US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
    • 30 Mar 2022 Z-1028-2022 Class II Terminated During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots. Distribution: US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.

Frequently asked questions

How many devices does Restor3D have in the registry?

The registry currently lists 3204 devices for Restor3D. Devices recorded under merged duplicate company entries are counted once.

Which registries list Restor3D's devices?

Among its 50 most recently registered devices, Restor3D has devices listed in FDA GUDID (50 devices).

What risk classes do Restor3D's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Restor3D's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Restor3D?

FDA recall records list 6 recalls initiated by Restor3D, the most recent initiated on 4 Sep 2026. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Restor3D in the registry?

The most recently registered devices listed for Restor3D include Veritas Instrumentation 6500-1120, Identity CR KA 5253-0001, Identity CR KA 5253-0002 and Identity CR KA 3DP Porous 5253-0021.

Generated automatically from registry data and not verified by a human reviewer.