PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
FDA Recall #Z-2555-2025 — Class II — June 24, 2025
Product Description
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Reason for 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.
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
3
Distribution
US Nationwide distribution in the states of CO, CA.
Code Information
UDI-DI: 18257200161010, Lots: 001, 002, and 003
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated