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.
Recall
- Recall Number
- Z-1592-2008
- Event Number
- 47424
- Firm
- Abbott Spine
- FEI Number
- 3000718496
- Product Code
- MNI
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- March 24, 2008
- Posted
- September 1, 2008
- Terminated
- December 2, 2009
- Address
- 12708 Riata Vista Cir, # B-100, Austin, TX, 78727-7167
Description
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.
Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site.
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.
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.
278 units.