Recall Z-1592-2008 ยท MNI Orthosis, Spinal Pedicle Fixation
Abbott Spine
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.
| Date | Sep 1, 2008 (initiated Mar 24, 2008) |
| Status | Terminated |
| Reason | Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site. |
| 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |