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
FDA Recall Z-3127-2017 · Posted 2017-08-18
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Recalling FirmOrthofix, Inc
Recall StatusTerminated
Product CodeNKB
Date Initiated2017-08-02
Date Terminated2018-05-04
Product Quantity6 planers
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distribution was made to distributors located in CA, FL, and RI. There was no foreign/military/government distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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