RegWardenFDA facility compliance records
Company

restor3d, inc.

3 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2022: 1 recalls; 2026: 2 recalls201720182019202020211202220232024202522026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2026-07-27
    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.
  • Class IIOngoing2026-06-30
    Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
  • Class IITerminated2022-03-30
    During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “restor3d, inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10058270-restor3d-inc/

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