Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant gr...
FDA Recall #Z-1432-2025 — Class II — February 20, 2025
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.
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.
Recalling Firm
Orthofix U.S. LLC — Lewisville, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
20
Distribution
US Nationwide distribution in the states of California, Colorado, and Missouri.
Code Information
(1) REF 82-3300SP - Lot Number 001, UDI 18257200160426; (2) REF 82-3700SP - Lot Number 001, UDI 18257200160884; and (3) REF 82-4000SP - Lot Number 001, UDI 18257200161270.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated