FDA Devices recall · Reported September 20, 2017
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
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.
Orthofix, Inc recalled Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, … - a moderate-severity action.
Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, … was recalled by Orthofix, Inc in September 20, 2017. Reason: The plastic core of the Decorticating Planer was found to be missing, which could result in scoring of the bo…. Check the official notice for the remedy. Verify recall #Z-3127-2017 with the FDA Devices before acting.
The recall
Orthofix, Inc issued this moderate-severity FDA Devices recall-The plastic core of the Decorticating Planer was found to be missing, which could result in scoring of the bo….
- Moderate
- severity level
- Class II
- classification
- September 20, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3127-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-3127-2017 |
| Date reported | September 20, 2017 |
| Date initiated | August 2, 2017 |
| Recalling firm | Orthofix, Inc |
| Firm location | Lewisville, TX |
| Affected scope | 6 planers |
| Distribution | Distribution was made to distributors located in CA, FL, and RI. There was no foreign/military/government distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-3127-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026