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U.S. Department of Health and Human Services

Class 2 Device Recall Axle Interspinous Fusion System Torque Driver Handle

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 Class 2 Recall
Axle Interspinous Fusion System Torque Driver Handle
see related information
Date Posted October 11, 2011
Recall Status1 Terminated on March 01, 2013
Recall Number Z-0034-2012
Recall Event ID 59756
Premarket Notification
510(K) Number
K101471 
Product Classification Curette, Surgical, General Use - 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, Ohio 45342-3658
Consumer Instructions Contact the recalling firm for information
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 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FZS and Original Applicant = X-SPINE SYSTEMS, INC.
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