FDAHealthJune 24, 2025
Orthofix U.S. LLC — PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 24, 2025
US Nationwide distribution in the states of CO, CA.
What's affected?
- Product
- PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
- Brand
- Orthofix U.S. LLC
- Lot code
- 001
Additional details
UDI-DI: 18257200161010, Lots: 001, 002, and 003
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3.
Get Health recall alerts
Delivered to your inbox. Free. No account required.