Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal… — Class II medical device recall Z-1432-2025
Ongoing recall by Orthofix U.S. LLC, reported 2025-04-02, distributed nationwide. The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and
| Recall number | Z-1432-2025 |
|---|---|
| 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 | 2025-02-20 |
| Classified | 2025-03-21 |
| Reported by FDA | 2025-04-02 |
| Distributed | Nationwide (US) |
| Quantity | 20 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 18257200160426, 18257200160884, 18257200161270 |
| Lot numbers | 001 |
| Model numbers | 10MMH, 24MMD, 28MMD, 32MMD, 33MMW, 37MMW, 40MMW, 82-3300SP, 82-3700SP, 82-4000SP |
Product
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 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.
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-1432-2025. 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.