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

• Date Initiated by Firm: April 27, 2016
• Date Posted: June 01, 2016
• Recall Status: Terminated on November 23, 2016
• Recall Number: Z-1881-2016
• Recall Event ID: 73978
• 510(K)Number: K153428
• Product Classification: Orthopedic Screwdriver - Product Code HXX
• Product: Firebird 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 Contact: Amy 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: Device Design
• Action: Affected 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 Commerce: 36 units
• Distribution: KS, NV, TX, CA, ID, FL, MA, MI, NJ, AZ, NH, SC, UT, WA
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = HXX and Original Applicant = ORTHOFIX INC.