Facility

SAFE ORTHOPAEDICS SAS

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

Key facts

1recalls · worst Class II

—inspections in our data

—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)	3009509485
Establishment type	Manufacture Medical Device
Location	Zone Dactivite De Montepy Fleurieux-Sur-L'Arbresle Rhone, FR 69210
Registration status	Active · expires 2026
Parent company	Safe Orthopaedics (owner-operator 10039164)
Brand names	STERISPINE LC Lumbar Interbody Device

Activity by year

Recalls (1)

Devices registered here (1)

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

Recalls & enforcement

Class IICompleted2022-06-03
The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct.

All facilities operated by Safe Orthopaedics

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. “SAFE ORTHOPAEDICS SAS (FEI 3009509485) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009509485-safe-orthopaedics-sas/

Not open yet

Alerts for SAFE ORTHOPAEDICS SAS

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.