Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns

FDA device recall Z-0034-2012 · posted 2011-10-11 · Terminated

Recall details

Recalling firm

X Spine Systems Inc

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.

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.

Root cause

Component design/selection

Status

Terminated

Product code

FZS

Quantity affected

39 Torque Driver Handles

Distribution

Nationwide Distribution including CA, CO, FL, IA, IN, LA, NY, PA, TN, TX and UT.

Date initiated

2011-07-15

Date posted

2011-10-11

Date terminated

2013-03-01

Location

Miamisburg, OH

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