InCompass Spinal Fixation System T-Handle Driver; Part #2151-4 (9.5" shaft) and 2151-5 (13" shaft); Non-sterile, Reusabl
FDA device recall Z-1592-2008 · 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
- 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.
- Date initiated
- 2008-03-24
- Date posted
- 2008-09-01
- Date terminated
- 2009-12-02
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM (K023644) | Spinal Concepts, Inc. | 2002-11-25 |
| INCOMPASS SPINAL FIXATION SYSTEM (K021564) | Spinal Concepts, Inc. | 2002-10-25 |