Facility

VGI medical, LLC

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

Key facts

1recalls · worst Class II

1inspections · 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)	3006982954
Establishment type	Manufacture Medical Device
Location	11651 87th St Largo, FL, US 33773
Registration status	Active · expires 2026
Parent company	VGI Medical, LLC (owner-operator 10026541)
Brand names	Facet Distractor

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Guide, Surgical, Instrument
Product code FZX (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4800

Recalls & enforcement

Class IITerminated2018-04-09
IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated

FDA inspections (1)

NAI2018-03-21
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 VGI Medical, LLC

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. “VGI medical, LLC (FEI 3006982954) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006982954-vgi-medical-llc/

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