Class 2 Device Recall Axle Interspinous Fusion System Torque Driver Handle

• Date Initiated by Firm: July 15, 2011
• Date Posted: October 11, 2011
• Recall Status: Terminated on March 01, 2013
• Recall Number: Z-0034-2012
• Recall Event ID: 59756
• 510(K)Number: K101471
• Product Classification: General and plastic surgery - Product Code FZS
• Product: Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
• Code Information: Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050
• Recalling Firm/ Manufacturer: X Spine Systems Inc; 452 Alexandersville Rd; Miamisburg OH 45342-3658
• For Additional Information Contact: David M. Letteri; 937-847-8400 Ext. 115
• Manufacturer Reason for Recall: The firm learned that the Torque Driver Handles were not actuating at a proper torque. It was determined that the handles were speed determinant and could output a higher torque if the handles were turned at a very slow speed.
• FDA Determined Cause: Component design/selection
• Action: X-spine Systems, Inc. sent an URGENT DEVICE RECALL letter dated September 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their stock immediately to determine if they have any affected product. If so, customers were instructed once the set screw is tightened onto the locking plate, and resistance is detected in the handle, it will take less than 2 seconds to hear the handle "click." The "click" indicates the torque limit was reached. If further resistance is felt after 2 seconds, the surgeon should release the handle from tension, and try again. If the product was distributed further, they should contact their accounts, and advise them of this recall. The firm will send replacement handles. For any questions call (937) 847-8400, ext 115.
• Quantity in Commerce: 39 Torque Driver Handles
• Distribution: Nationwide Distribution including CA, CO, FL, IA, IN, LA, NY, PA, TN, TX and UT.
• 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 = FZS