Lower riskMedical device recall · FDA · Published February 20, 2025
Orthofix Pillar SA Ti Spacer System: Incorrect Height Labeling Risk
Orthofix recalls three spinal implant models due to mislabeled anterior height (10mm vs 10.5mm). This could affect spinal fusion surgery accuracy. Contact Orthofix for details.
The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.
Take action
Contact the company
📍Recalling firmOrthofix U.S. LLC3451 Plano Pkwy · Lewisville, TX 75056-9453
✎ GovInfoNow plain-language explainer
Orthofix is recalling three specific spinal fusion implants because they're labeled with the wrong height (10mm instead of 10.5mm). This labeling error might cause improper spinal fusion during surgery. Patients using these implants should contact Orthofix for guidance. Read more at govinfonow.com/recall/52786-orthofix-pillar-sa-ti-spacer-system-incorrect-height-labeling-risk.
“Orthofix Pillar SA Ti Spacer System: Incorrect Height Labeling Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52786-orthofix-pillar-sa-ti-spacer-system-incorrect-height-labeling-risk. Based on FDA recall #Z-1432-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1432-2025%22&limit=1).
Orthofix U.S. LLC recalled Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Devices due to mislabeling of the anterior height, according to the FDA on Feb. 20, 2025. The hazard involves incorrect labeling where the product shows a 10mm height while the implant and trial indicate 10.5mm.
How to tell if you have it
Brand: Orthofix
Product: Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy
REF 82-3300SP, Lot Number 001, UDI 18257200160426
REF 82-3700SP, Lot Number 001, UDI 18257200160884
REF 82-4000SP, Lot Number 001, UDI 18257200161270
The hazard
The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.
Context
GovInfoNow's records show Orthofix U.S. LLC has 4 other recalls on record since June 24, 2025. Other recent recalls include the Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS (June 10, 2026), FIREBIRD SI Fusion System (Nov. 3, 2025), and Orthofix Virata Preassembled Polyaxial Screws (Sept. 19, 2025). Other recent recalls of similar products include the Micro Therapeutics Pipeline Flex Embolization Device (June 8, 2026) and Centinel Spine Prodisc C SK U.S. Implant Extra Large 6mm (March 20, 2026).
How to tell if you have this one
Check if your implant has the model numbers REF 82-3300SP, 82-3700SP, or 82-4000SP with a height of 10mm. The specific lot numbers and UDI codes are listed in the recall notice.
Brand
Orthofix
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Orthofix
Reach out to Orthofix directly for guidance on whether your implant is affected and next steps.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of California, Colorado, and Missouri.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Missouri.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1432-2025 (February 20, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1432-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.