Lower risk Medical device recall · FDA · Published June 24, 2025

Orthofix PILLAR SA Ti 37mm Fusion Device Recall: Labeling Discrepancy

Orthofix recalls specific 37mm PILLAR SA Ti spinal fusion devices due to incorrect label width measurements. This labeling error may cause improper surgical use. Affected devices have UDI-DI: 18257200161010 and lots 001-003.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2555-2025Medical device Orthofix ›

Lower-risk recall

A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.

Take action

Contact the company

Recalling firmOrthofix U.S. LLC3451 Plano Pkwy · Lewisville, TX 75056-9453

✎ GovInfoNow plain-language explainer

Orthofix is recalling certain spinal fusion devices because their labels incorrectly state a 33mm width instead of the actual 37mm. This labeling error could lead to improper surgical use if the device is not correctly sized. Read more at govinfonow.com/recall/51972-orthofix-pillar-sa-ti-37mm-fusion-device-recall-labeling-discrepancy.

Source Summary by GovInfoNow · govinfonow.com/recall/51972-orthofix-pillar-sa-ti-37mm-fusion-device-recall-labeling-discrepancy · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2555-2025

Cite this page

“Orthofix PILLAR SA Ti 37mm Fusion Device Recall: Labeling Discrepancy.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/51972-orthofix-pillar-sa-ti-37mm-fusion-device-recall-labeling-discrepancy. Based on FDA recall #Z-2555-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2555-2025%22&limit=1).

Orthofix U.S. LLC recalled one PILLAR SA Ti intervertebral body fusion device due to a labeling discrepancy stating an incorrect width on the outer and inner flaps, according to the FDA. The Food and Drug Administration announced the Class II recall on June 24, 2025.

How to tell if you have it

Brand: Orthofix
Product: PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees
REF: 82-3713SP
UDI-DI: 18257200161010
Lots: 001, 002, and 003

The hazard

The 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.

Context

GovInfoNow's records show Orthofix U.S. LLC has 4 other recalls on record since 2025-02-20. Other recent recalls of similar products include FORZA PTC Spacer System (2025-11-03), Orthofix Virata Preassembled Polyaxial Screws (2025-09-19), and Micro Therapeutics Pipeline Flex Embolization Device (2026-06-08).

How to tell if you have this one

Check for the product name 'PILLAR SA Ti', sterile, 37mm width, 20-degree angle, and reference number 82-3713SP. Devices with UDI-DI: 18257200161010 and lots 001, 002, or 003 are affected.

Brand
Orthofix
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Labels
Verify the device's width on the front label is 37mm and the inner label states 37mm, not 33mm.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 2 states.

FDA distribution: “US Nationwide distribution in the states of CO, CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado.

Recall timeline

FDA published this recall 3 months after the firm started it.

Jun 24, 2025Firm started the recall
Sep 11, 2025FDA classified it Class II
Sep 17, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to do anything with this device?

The recall does not require immediate action; check the labels to ensure the correct width is stated.

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Link to this recall

<a href="https://govinfonow.com/recall/51972-orthofix-pillar-sa-ti-37mm-fusion-device-recall-labeling-discrepancy">Orthofix PILLAR SA Ti 37mm Fusion Device Recall: Labeling Discrepancy (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2555-2025 (June 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2555-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.