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U.S. Department of Health and Human Services

Class 2 Device Recall THandle Driver

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 Class 2 Device Recall THandle Driversee related information
Date Initiated by FirmMarch 24, 2008
Date PostedSeptember 01, 2008
Recall Status1 Terminated 3 on December 02, 2009
Recall NumberZ-1593-2008
Recall Event ID 47424
510(K)NumberK030625 K071174 
Product Classification Orthosis, Spinal Pedicle Fixation - Product Code MNI
ProductPathFinder Spinal Fixation System T-Handle Driver; Part 2151-7 (13" shaft); Non-sterile, Reusable Instrument; manufactured by Abbott Spine, Austin, TX 78727.
Code Information All lots.
FEI Number 3000718496
Recalling Firm/
Manufacturer		 Abbott Spine
12708 Riata Vista Cir # B-100
Austin TX 78727-7167
For Additional Information Contact
512-918-2700
Manufacturer Reason
for Recall		Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site.
FDA Determined
Cause 2		Error in labeling
ActionFirm 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.
Quantity in Commerce224 units.
DistributionNationwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MNI
510(K)s with Product Code = MNI
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