Z-1784-2008

PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2; distributed by Abbott Spine, Inc., Austin, TX...

Name: Z-1784-2008 PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2; distributed by Abbott Spine, Inc., Austin, TX...
Creator: Abbott Spine
Published: 2008-04-17
License: https://open.fda.gov/license/

Spinal Concepts, Inc. / initiated 2008-04-17 / Terminated / root cause: design

FDA source

Abbott Spine began a recall of PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2; distributed by Abbott Spine, Inc., Austin, TX 78727 on 2008-04-17. The reason FDA records is "Breakage - Tips on the Pathfinder Bone Awl may bend or break prematurely. The firm has received internal non-conformances and complaints where the tips of the Awl were worn and damaged. Of the tip breaks, six have had...". 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-1784-2008
Status: Terminated
Initiated: 2008-04-17
Posted: 2008-09-05
Terminated: 2009-12-02
Recalling firm: Spinal Concepts, Inc.
Product: PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2; distributed by Abbott Spine, Inc., Austin, TX 78727.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Breakage - Tips on the Pathfinder Bone Awl may bend or break prematurely. The firm has received internal non-conformances and complaints where the tips of the Awl were worn and damaged. Of the tip breaks, six have had material missing. During the same period, there were 15 complaints reported where the tip broke off at the weld after repeated use (1-3 years). The firm found several possible ca
Root cause tag: design
FDA root cause: Device Design
Action: Phone calls and emails were used to disseminate information about this recall. Firm notified consignees via telephone beginning on 04/17/08. Consignees were told that some problems were found through normal wear and tear as well as product mis-use and material weaknesses. The firm explained that they noticed from wear and tear from use as well as damage from use could cause the tip to become dull and flared causing breakage. The firm explained that they redesigned the awl and requested that consignees return outstanding inventory, which will be replaced with a new version of the awl.
Quantity in commerce: 180 units.
Distribution: Class II Recall - Worldwide Distribution --- USA including states of AR, AZ, CA, CT, CO, FL, IL, MD, MI, MO, MT, NC, NJ, NV, NY, NM, OH, OK, PA, SD, TX and WI, and countries of Argentina, Australia, Belgium, Canada, China, Columbia, Cyprus, Germany, Greece, Italy, Japan, Mexico, Thailand, Turkey and UK/Ireland.
Product codes and lots: All lots.

Product code NKB

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)