Orthofix U.S. LLC: Device Recall

Recall #Z-1432-2025 · 02/20/2025

Class II: Risk

Recall Details

Recall Number
Z-1432-2025
Classification
Class II
Product Type
Device
Recalling Firm
Orthofix U.S. LLC
Status
Ongoing
Date Initiated
02/20/2025
Location
Lewisville, TX, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20

Reason for Recall

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.

Product Description

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.

Distribution Pattern

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

Other Recalls by Orthofix U.S. LLC

View all recalls by Orthofix U.S. LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.