FDA Enforcement
Class II
Ongoing
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.
Recall: Z-1432-2025
·
Reported April 2, 2025
Enforcement
- Recall Number
- Z-1432-2025
- Event ID
- 96351
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Orthofix U.S. LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- N/A
- Report Date
- April 2, 2025
- Initiation Date
- February 20, 2025
- Classification Date
- March 21, 2025
- Address
- 3451 Plano Pkwy, N/A, Lewisville, TX, 75056-9453, United States
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
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.
Code Info
(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.
Distribution
US Nationwide distribution in the states of California, Colorado, and Missouri.
Quantity
20