PathFinder Spinal Fixation System T-Handle Driver; Part 2151-7 (13" shaft); Non-sterile, Reusable Instrument; manufactur

FDA device recall Z-1593-2008 · posted 2008-09-01 · Terminated

Recall details

Recalling firm

Abbott Spine

Reason for recall

Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site.

Action taken

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.

Root cause

Error in labeling

Status

Terminated

Product code

MNI

Quantity affected

224 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.

Date initiated

2008-03-24

Date posted

2008-09-01

Date terminated

2009-12-02

Location

Austin, TX

Related 510(k) clearances