Firebird NXG Spinal Fixation System Decorticating Planer — Class II medical device recall Z-3127-2017
Terminated recall by Orthofix, Inc, reported 2017-09-20, distributed in CA, FL, RI. The plastic core of the Decorticating Planer was found to be missing, which could result in scoring of the bon
| Recall number | Z-3127-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthofix, Inc, Lewisville, TX, United States |
| Recall initiated | 2017-08-02 |
| Classified | 2017-09-12 |
| Reported by FDA | 2017-09-20 |
| Terminated | 2018-05-04 |
| Distributed | CA, FL, RI |
| Quantity | 6 planers |
| Lot numbers | 203013-TD26 |
| Model numbers | 36-1334 |
Product
Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decorticate bone surrounding the spherical head of an implanted bone screw in order to provide clearance to allow for proper seating of the modular body, as well as to provide full range of modular body angulation. It is placed axially over the spherical head of the bone screw and rotated clockwise and counterclockwise to achieve the needed decortication
Reason for recall
The plastic core of the Decorticating Planer was found to be missing, which could result in scoring of the bone screw neck if used at or beyond a 23 degree angle.
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-3127-2017. 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.