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.
FDA Recall Z-1592-2008 · Posted 2008-09-01
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Recalling FirmAbbott Spine
Recall StatusTerminated
Product CodeMNI
Date Initiated2008-03-24
Date Terminated2009-12-02
Product Quantity278 units.
Reason for Recall
Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site.
Firm 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 have not received the recall notice from the firm, contact Kirstin Widding at 512-533-1852.
Root Cause
Error in labeling
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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