Facility

OrthAlign, Inc.

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

Key facts

1recalls · 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)	3007521480
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	153 Technology Irvine, CA, US 92618
Registration status	Active · expires 2026
Parent company	OrthAlign, Inc (owner-operator 10028839)

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Orthopedic Stereotaxic Instrument
Product code OLO (opens in a new tab) · Class II · Neurology · 21 CFR 882.4560

Recalls & enforcement

Class IIOngoing2026-02-10
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)

FDA inspections (2)

NAI2022-04-28
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2017-05-02
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

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 OrthAlign, 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. “OrthAlign, Inc. (FEI 3007521480) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007521480-orthalign-inc/

Not open yet

Alerts for OrthAlign, Inc.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.