PILLAR SA Ti — Class II medical device recall Z-2555-2025
Ongoing recall by Orthofix U.S. LLC, reported 2025-09-17, distributed nationwide. A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33
| Recall number | Z-2555-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthofix U.S. LLC, Lewisville, TX, United States |
| Recall initiated | 2025-06-24 |
| Classified | 2025-09-11 |
| Reported by FDA | 2025-09-17 |
| Distributed | Nationwide (US) |
| Quantity | 3 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 18257200161010 |
| Lot numbers | 001, 002, 003 |
| Model numbers | 82-3713SP |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2555-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.