Facility

GAUTHIER BIOMEDICAL, INC.

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

Key facts

1recalls · worst Class II

3inspections · 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)	3010938185
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	2221 Washington St Grafton, WI, US 53024
Registration status	Active · expires 2026
Parent company	GAUTHIER BIOMEDICAL, INC. (owner-operator 9041205)

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (2)

Appliance, Fixation, Spinal Intervertebral Body
Product code KWQ (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3060
Thoracolumbosacral Pedicle Screw System
Product code NKB (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3070

Recalls & enforcement

Class IIOngoing2024-11-11
An out of specification component may result in the device exhibiting torque output higher than the design specification.

FDA inspections (3)

NAI2025-01-08
No Action Indicated · Compliance: Devices
VAI2021-12-21
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2016-12-15
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 GAUTHIER BIOMEDICAL, 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. “GAUTHIER BIOMEDICAL, INC. (FEI 3010938185) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010938185-gauthier-biomedical-inc/

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