Class 2 Device Recall Fortex Pedicle Screw System Continuous Radius Rod 5.5 50mm, XSpine Systems, Inc.

• Date Initiated by Firm: April 07, 2015
• Date Posted: June 22, 2015
• Recall Status: Terminated on October 01, 2015
• Recall Number: Z-1823-2015
• Recall Event ID: 71357
• 510(K)Number: K120832
• Product Classification: Orthosis, spondylolisthesis spinal fixation - Product Code MNH
• Product: Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
• Code Information: Model #: N60001068; Lot #: 2943-01; Serial #s: 46118, 46581, 47296, 47588, 47653, 48164, 48201, 48412, 49156, 49585, 49586, 49649, G22, G45, G47, G77, G83, G87X, G90X, R15, XP03, XP21, XP27, XP28, XP29 & XP32.
• FEI Number: 3005031160
• Recalling Firm/ Manufacturer: X Spine Systems Inc; 452 Alexandersville Rd; Miamisburg OH 45342-3658
• For Additional Information Contact: Mr. Kriss E. Anderson; 937-847-8400 Ext. 137
• Manufacturer Reason for Recall: The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
• FDA Determined Cause: Other
• Action: X-Spine sent an Urgent Medical Device Recall Letter dated April 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: 1. The affected hospital and surgeon should be notified of this recall immediately. 2. Complete the attached Medical Device Recall Return Response Form and return it with any affected product in inventory to X-Spine Systems immediately. a. Reference RMA # 5410 b. Use enclosed shipping label 3. No action should be taken with product that has been implanted. Please feel free to contact me at 800.903.0640 ext. 137.
• Quantity in Commerce: 75 units
• Distribution: Worldwide Distribution - US Distribution to the states of : FL, ID, IL, KS, LA, MI, MO, NJ, OH, PA and TX., and to the countries of Austria, Germany and Italy.
• 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 = MNH