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U.S. Department of Health and Human Services

Class 2 Device Recall Firebird NXG Spinal Fixation System Decorticating Planer

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 Class 2 Device Recall Firebird NXG Spinal Fixation System Decorticating Planersee related information
Date Initiated by FirmAugust 02, 2017
Date PostedAugust 18, 2017
Recall Status1 Terminated 3 on May 04, 2018
Recall NumberZ-3127-2017
Recall Event ID 77882
510(K)NumberK171082 
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
ProductFirebird 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 Lot #203013-TD26
Recalling Firm/
Manufacturer		 Orthofix, Inc
3451 Plano Pkwy
Lewisville TX 75056-9453
For Additional Information ContactJacki Koch
214-937-2100
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOrthofix 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 in Commerce6 planers
DistributionDistribution was made to distributors located in CA, FL, and RI. There was no foreign/military/government distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NKB
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