Facility

CLARIANCE-SAS

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

Key facts

2recalls · 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)	3008992889
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	18, rue Robespierre BEAURAINS Hauts-de-France, FR 62217
Registration status	Active · expires 2026
Parent company	CLARIANCE-SAS (owner-operator 10043711)

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (2)

Intervertebral Fusion Device With Bone Graft, Lumbar
Product code MAX (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3080
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Product code OVD (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3080

Recalls & enforcement

Class IIOngoing2026-02-20
Due to a quality issue regarding the presence of burr on the finished cervical plate product.
Class IIITerminated2019-07-01
Potential for the polyaxial screw to become disassembled during implant.

FDA inspections (2)

VAI2024-09-26
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2018-06-14
No Action Indicated · Compliance: 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.

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. “CLARIANCE-SAS (FEI 3008992889) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008992889-clariance-sas/

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