ORTHOFIX Firebird Spinal Fixation System 6 — Class II medical device recall Z-1749-2015
Terminated recall by Orthofix, Inc, reported 2015-06-17, distributed in CA, CO, FL, MD, MI, NY, OK, PA…. The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabeled at the dis
| Recall number | Z-1749-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthofix, Inc, Lewisville, TX, United States |
| Recall initiated | 2015-05-18 |
| Classified | 2015-06-10 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2015-10-30 |
| Distributed | CA, CO, FL, MD, MI, NY, OK, PA, SC |
| Countries outside the US | ES |
| Quantity | 45 units |
| Reason classes | labeling |
| Lot numbers | S29 |
Product
ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse
Reason for recall
The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabeled at the distal tip of the bone screw showing a length measurement of 50 mm instead of 55 mm.
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-1749-2015. 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.