Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1)
FDA device recall Z-1432-2025 · posted 2025-03-21 · Open, Classified
Recall details
- Recalling firm
- Orthofix U.S. LLC
- 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.
- Action taken
- On 2/20/2025, correction notices were emailed to distributors who were informed of the following: This notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred. Attach this notice to the inventory in your possession, if possible. Should you have any questions regarding this matter, please contact the firm at madison.ebel@seaspine.com
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- MAX
- Quantity affected
- 20
- Distribution
- US Nationwide distribution in the states of California, Colorado, and Missouri.
- Date initiated
- 2025-02-20
- Date posted
- 2025-03-21
- Location
- Lewisville, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PILLAR SA Ti Spacer System (82-XXX) (K240749) | Orthofix, Inc. | 2024-05-28 |