Z-1592-2008

InCompass Spinal Fixation System T-Handle Driver; Part #2151-4 (9.5" shaft) and 2151-5 (13" shaft)...

Name: Z-1592-2008 InCompass Spinal Fixation System T-Handle Driver; Part #2151-4 (9.5" shaft) and 2151-5 (13" shaft)...
Creator: Abbott Spine
Published: 2008-03-24
License: https://open.fda.gov/license/

Spinal Concepts, Inc. / initiated 2008-03-24 / Terminated / root cause: labeling and UDI

FDA source

Abbott Spine began a recall of InCompass Spinal Fixation System T-Handle Driver; Part #2151-4 (9.5" shaft) and 2151-5 (13" shaft); Non-sterile, Reusable Instrument; manufactured by Abbott... on 2008-03-24. The reason FDA records is "Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1592-2008
Status: Terminated
Initiated: 2008-03-24
Posted: 2008-09-01
Terminated: 2009-12-02
Recalling firm: Spinal Concepts, Inc.
Product: InCompass Spinal Fixation System T-Handle Driver; Part #2151-4 (9.5" shaft) and 2151-5 (13" shaft); Non-sterile, Reusable Instrument; manufactured by Abbott Spine, Austin, TX 78727.
Product code: MNI Orthosis, Spinal Pedicle Fixation
Reason for recall: Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Firm sent notification letters to sales agents via letter on 03/24/08. Enclosed with the notification letter, the firm provided updated product inserts for the InCompass and PathFinder Spinal Fixation System (Cat. #2199-0002-LB Rev. H and #1199-0002-LB Rev. H, respectively), as well as the "Disassembly and Assembly Instructions for PathFinder & InCompass T-Handle Drivers" (Cat #1199-0040-MKC Rev. A). Sales Agents instructed to distribute updated inserts and instructions to all locations that handle the drivers for cleaning and to destroy all copies of old inserts. If you have questions or have not received the recall notice from the firm, contact Kirstin Widding at 512-533-1852.
Quantity in commerce: 278 units.
Distribution: Nationwide Distribution --- including states of AR, AZ, CA, CT, CO, FL, IL, LA, MD, MI, MO, MN, MT, NC, NM, NJ, NY, OH, OK, OR, PA, SD, TX, VA and WI.
Product codes and lots: All lots.

Product code MNI

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)