FDA Medical Device Recalls (openFDA)
Abbott Spine: PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2; distributed by Abbott Spine, Inc., Austin, TX 78727.
- Recall number
- Z-1784-2008
- Recalling firm
- Abbott Spine
- Product
- PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2; distributed by Abbott Spine, Inc., Austin, TX 78727.
- Status
- Terminated
- Initiated
- 2008-04-17
- Posted
- 2008-09-05
- Terminated
- 2009-12-02
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- ["K030625","K071174"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 3000718496
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28