FDA Medical Device Recalls (openFDA)
Orthofix, Inc: 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
- Recall number
- Z-3127-2017
- Recalling firm
- Orthofix, Inc
- 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
- Status
- Terminated
- Initiated
- 2017-08-02
- Posted
- 2017-08-18
- Terminated
- 2018-05-04
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 6 planers
- Distribution
- Distribution was made to distributors located in CA, FL, and RI. There was no foreign/military/government distribution.
- Lot, serial or model codes
- Lot #203013-TD26
- 510(k) numbers
- ["K171082"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 2183449
- Firm city
- Lewisville
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28