Orthofix U.S product recalled over labeling errors

Recall date

February 20, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Orthofix U.S. LLC recalls Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1…

Recall number

Z-1432-2025

FDA classification

Class II

Brand / firm

Orthofix U.S. LLC

Sold / distributed

US Nationwide distribution in the states of California, Colorado, and Missouri.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees; (2) REF 82-3700SP, 37mm W x 28mm D x 10mm H, 7 degrees; and (3) REF 82-4000SP, 40mm W x 32mm D x 10mm H, 7 degrees.