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.
- Company
- Abbott Spine
- Recall Initiated
- March 24, 2008
- Posted
- September 1, 2008
- Terminated
- December 2, 2009
- Recall Number
- Z-1592-2008
- Quantity
- 278 units.
- Firm Location
- Austin, TX
Reason for Recall
Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site.
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.
Lot / Code Info
All lots.
Root Cause
Error in labeling
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.