Facility

BLUE ORTHO

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

Key facts

3recalls · worst Class II

1inspections · worst NAI

—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)	3008027912
Establishment type	Manufacture Medical Device
Location	22 Chemin du Vieux Chene Meylan Isere, FR 38240
Registration status	Active · expires 2026
Parent company	BLUE ORTHO (owner-operator 10037278)
Brand names	ExactechGPS System

Activity by year

Recalls (3)
Inspections (1)

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 IIOngoing2024-08-30
Predict+ is being recalled for lack of pre-market clearance/approval.
Class IITerminated2020-09-10
Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents.
Class IITerminated2019-09-22
The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).

FDA inspections (1)

NAI2024-04-11
No 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 BLUE ORTHO

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. “BLUE ORTHO (FEI 3008027912) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008027912-blue-ortho/

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