Events

Recall of Device Recall Axle Interspinous Fusion System Torque Driver Handle

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by X Spine Systems Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59756
  • Event Risk Class
    Class 2
  • Event Number
    Z-0034-2012
  • Event Initiated Date
    2011-07-15
  • Event Date Posted
    2011-10-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103598
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    General and plastic surgery - Product Code FZS
  • Reason
    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.
  • 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.

Device

Device Recall Axle Interspinous Fusion System Torque Driver Handle
  • Model / Serial
    Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including CA, CO, FL, IA, IN, LA, NY, PA, TN, TX and UT.
  • Product Description
    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.
  • Manufacturer
    X Spine Systems Inc

Manufacturer

X Spine Systems Inc
  • Manufacturer Address
    X Spine Systems Inc, 452 Alexandersville Rd, Miamisburg OH 45342-3658
  • Manufacturer Parent Company (2017)
    X-Spine Systems, Inc
  • Source
    USFDA