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.
This recall has been terminated (originally issued October 11, 2011).
- Company
- X Spine Systems Inc
- Recall Initiated
- July 15, 2011
- Posted
- October 11, 2011
- Terminated
- March 1, 2013
- Recall Number
- Z-0034-2012
- Quantity
- 39 Torque Driver Handles
- Firm Location
- Miamisburg, OH
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution including CA, CO, FL, IA, IN, LA, NY, PA, TN, TX and UT.
Lot / Code Info
Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050
Root Cause
Component design/selection
Action Taken
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.