Facility

SURGICAL THEATER, INC.

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

Key facts

1recalls · worst Class II

4inspections · 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)	3010197287
Establishment type	Manufacture Medical Device; Complaint File Establishment per 21 CFR 820.198
Location	23645 Mercantile Road Beachwood, OH, US 44122
Registration status	Active · expires 2026
Parent company	Surgical Theater, Inc. (owner-operator 10044065)
Brand names	SpineAR SNAP

Activity by year

Recalls (1)
Inspections (4)

Devices registered here (1)

Orthopedic Augmented Reality
Product code SBF (opens in a new tab) · Class II · Neurology · 21 CFR 882.4560

Recalls & enforcement

Class IITerminated2025-09-16
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.

FDA inspections (4)

VAI2026-06-11
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2023-03-03
Voluntary Action Indicated · Compliance: Devices · citations posted
NAI2019-02-07
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2017-02-23
Voluntary 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 Surgical Theater, 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. “SURGICAL THEATER, INC. (FEI 3010197287) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010197287-surgical-theater-inc/

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