Facility

restor3d, inc.

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

Key facts

3recalls · worst Class II

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3014833750
Establishment type	Manufacture Medical Device
Location	4001 NC Hwy 54, Suite 2160 Durham, NC, US 27709
Registration status	Active · expires 2026
Parent company	restor3d, inc. (owner-operator 10058270)
Brand names	restor3d Disposable Instruments, Cervical Cage

Activity by year

Recalls (3)
Inspections (2)

Devices registered here (1)

Orthopedic Manual Surgical Instrument
Product code LXH (opens in a new tab) · Class I · Orthopedic · 21 CFR 888.4540

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.

FDA inspections (2)

VAI2024-06-14
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Project Evaluation: Devices · citations posted
NAI2023-05-12
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by restor3d, inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “restor3d, inc. (FEI 3014833750) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3014833750-restor3d-inc/

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