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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77882

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
August 02, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Orthofix, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-3127-2017
Recall number
Z-3127-2017
Initiated
August 02, 2017
Classification
Class II
Status
Terminated
Recalling firm
Orthofix, Inc
Quantity
6 planers

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot #203013-TD26

Distribution pattern

Distribution was made to distributors located in CA, FL, and RI. There was no foreign/military/government distribution.