Firebird NXG Spinal Fixation System Decorticating Planer… recallZ-3127-2017 · Orthofix, Inc · initiated Aug 2, 2017
Class II Terminated All recalls posted in August 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Orthofix, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Orthofix sent an Urgent Medical Device Product Recall letter dated August 2, 2017, to all affected customers. The letter explained the issue and requested return of product in their possession. Customers with questions were instructed to contact their local Orthofix representative. For questions regarding this recall call 214-937-2100.
Recall details
- Recall number
- Z-3127-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 2, 2017
- Posted by the FDA
- Aug 18, 2017
- Recalling firm
- Orthofix, Inc
- Quantity
- 6 planers
- Product code
- NKB
- FDA submissions
- K171082
- Distribution
- Distribution was made to distributors located in CA, FL, and RI. There was no foreign/military/government distribution.
Product description
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
Code information (models, lots, serial numbers)
Lot #203013-TD26
Other devices under the same FDA submission
1 device cleared under K171082 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Firebird 44-5545 BEOrthofix US LLC · Thoracolumbosacral Pedicle Screw System1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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