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U.S. Department of Health and Human Services

Class 2 Device Recall Firebird NXG Spinal Fixation System Set Screw Driver

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 Class 2 Device Recall Firebird NXG Spinal Fixation System Set Screw Driversee related information
Date Initiated by FirmApril 27, 2016
Date PostedJune 01, 2016
Recall Status1 Terminated 3 on November 23, 2016
Recall NumberZ-1881-2016
Recall Event ID 73978
510(K)NumberK153428 
Product Classification Orthopedic Screwdriver - Product Code HXX
ProductFirebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile.
Code Information All lots
Recalling Firm/
Manufacturer		 Orthofix, Inc
3451 Plano Pkwy
Lewisville TX 75056-9453
For Additional Information ContactAmy Weaver
214-937-2200
Manufacturer Reason
for Recall		There is a possibility that the subject set screw driver could disengage from the torque limiting handle when the counter torque wrench is allowed to contact the counter torque handle.
FDA Determined
Cause 2		Device Design
ActionAffected distributors will be provided a written notification of field correction via USPS Certified Mail or FedEx on 4/27/16. Distributors will be additionally instructed to provide field correction notifcations to hospitals, surgeons, or other distributors that they may have further ditributed the product to.
Quantity in Commerce36 units
DistributionKS, NV, TX, CA, ID, FL, MA, MI, NJ, AZ, NH, SC, UT, WA
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 = HXX
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