FDA Device recall Z-3127-2017
Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decorticate…
- FDA Device
- Class II
- terminated
- Published 2017-09-20
On 2017-09-20 the FDA classified a Class II recall of Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decorticate… by Orthofix, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3127-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-02 |
| Published | 2017-09-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Orthofix |
| Distribution | CA, FL, RI |
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
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.
Identifiers
| code_info | Lot #203013-TD26 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3127-2017%22
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