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Class 2 Device Recall THandle Driver |
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Date Initiated by Firm |
March 24, 2008 |
Date Posted |
September 01, 2008 |
Recall Status1 |
Terminated 3 on December 02, 2009 |
Recall Number |
Z-1593-2008 |
Recall Event ID |
47424 |
510(K)Number |
K071174 K030625
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Product Classification |
Orthosis, Spinal Pedicle Fixation - Product Code MNI
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Product |
PathFinder¿ 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. |
Recalling Firm/ Manufacturer |
Abbott Spine 12708 Riata Vista Cir # B-100 Austin TX 78727-7167
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For Additional Information Contact |
512-918-2700
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Manufacturer Reason for Recall |
Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site.
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FDA Determined Cause 2 |
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 have not received the recall notice from the firm, contact Kirstin Widding at 512-533-1852. |
Quantity in Commerce |
224 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. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = MNI and Original Applicant = ABBOTT SPINE, INC. 510(K)s with Product Code = MNI and Original Applicant = SPINAL CONCEPTS, INC.
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