Z-0004-2008

PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50

Name: Z-0004-2008 PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50
Creator: Abbott Spine
Published: 2007-07-18
License: https://open.fda.gov/license/

Spinal Concepts, Inc. / initiated 2007-07-18 / Terminated / root cause: design

FDA source

Abbott Spine began a recall of PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50 on 2007-07-18. The reason FDA records is "Tip of PathFinder surgical instrument broke during procedure". 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-0004-2008
Status: Terminated
Initiated: 2007-07-18
Posted: 2007-10-02
Terminated: 2008-04-02
Recalling firm: Spinal Concepts, Inc.
Product: PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Tip of PathFinder surgical instrument broke during procedure.
Root cause tag: design
FDA root cause: Device Design
Action: Firm notified sales representatives with an approved phone script on 7/18/2007.
Quantity in commerce: 11 units
Distribution: Nationwide.
Product codes and lots: Part Numbers 1156-50, lot number 44QR.

Product code NKB

K030625Class IISpinal Concepts Inc. PathfinderSpinal Concepts, Inc. / cleared 2003-03-28

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)