Facility

Nevro Medical S.R.L.

6 recall(s) on record — most severe on record: Class I.

Key facts

6recalls · worst Class I

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)	3020969413
Establishment type	Manufacture Medical Device
Location	Building 28-C, Coyol Free Zone Park C.R El Coyol Alajuela, CR 20101
Registration status	Active · expires 2026
Parent company	Globus Medical, Inc (owner-operator 10030390)
Brand names	Senza Spinal Cord Stimulation (SCS) System

Activity by year

Recalls (6)
Inspections (1)

Devices registered here (2)

Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy
Product code QRB (opens in a new tab) · Class III · Unknown
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Product code LGW (opens in a new tab) · Class III · Unknown

Recalls & enforcement

Class IIOngoing2025-04-03
Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.
Class IIOngoing2023-12-15
Devices may not be rendered sterile due to an internal gap that may be present on some devices causing increased difficulty cleaning prior to steam sterilization. There is an increased risk for infection, inflammation, local toxicity, systemic toxicity, sensitivity, and cross-con…
Class IIOngoing2023-12-11
Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
Class IOngoing2023-12-07
A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement.
Class IITerminated2020-07-22
Specific lots of ALTERA® implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Class IITerminated2013-08-28
The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.

FDA inspections (1)

NAI2022-07-29
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.

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. “Nevro Medical S.R.L. (FEI 3020969413) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3020969413-nevro-medical-s-r-l/

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