Z-0034-2012

Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot #...

Name: Z-0034-2012 Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot #...
Creator: X Spine Systems Inc
Published: 2011-07-15
License: https://open.fda.gov/license/

Xtant Medical Holdings, Inc. / initiated 2011-07-15 / Terminated / root cause: design

FDA source

X Spine Systems Inc began a recall of 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... on 2011-07-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0034-2012
Status: Terminated
Initiated: 2011-07-15
Posted: 2011-10-11
Terminated: 2013-03-01
Recalling firm: Xtant Medical Holdings, Inc.
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.
Product code: FZS Curette, Surgical, General Use
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.
Root cause tag: design
FDA root 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.
Product codes and lots: Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050

Product code FZS

K101471Class IIAxle Interspinous Fusion SystemX-Spine Systems, Inc. / cleared 2010-11-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)