Medical Device Recall: Z-0034-2012

FDA Recalls dataset · Firm: X Spine Systems Inc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2011-07-15 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0034-2012.

Recall Res Number
Z-0034-2012
Recalling Firm / Manufacturer
X Spine Systems Inc
FEI Number
3005031160
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2011-07-15
Date Posted
2011-10-11
Date Terminated
2013-03-01
Product Code
FZS
Event Number
59756
Product Quantity
39 Torque Driver Handles
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.
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 Details 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.
Distribution Pattern Nationwide Distribution including CA, CO, FL, IA, IN, LA, NY, PA, TN, TX and UT.
Code Information / Serial Numbers Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050

Related Establishments / Registrations

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