ClearanceBrief
Recall Z-0005-2008 ยท NKB Thoracolumbosacral Pedicle Screw System

Abbott Spine

PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.

DateOct 2, 2007 (initiated Jul 18, 2007)
StatusTerminated
ReasonTip of PathFinder surgical instrument broke during procedure.
Root causeDevice Design
ActionFirm notified sales representatives with an approved phone script on 7/18/2007.
Quantity11 units
DistributionNationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K030625SPINAL CONCEPTS INC. PATHFINDER
Spinal Concepts, Inc., Mar 28, 2003