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U.S. Department of Health and Human Services

Class 2 Device Recall TraXis Fixed Trial

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  Class 2 Device Recall TraXis Fixed Trial see related information
Date Initiated by Firm November 07, 2006
Date Posted January 17, 2007
Recall Status1 Terminated 3 on October 11, 2007
Recall Number Z-0354-2007
Recall Event ID 36731
510(K)Number K060841  
Product Classification spinal implant - Product Code MQP
Product TraXis Fixed Trial in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; part of TraXis vertebral body replacement system
Code Information Part #2665-1-07 (7mm), 2665-1-09 (9mm), 2665-1-11 (11mm), 2665-1-13 (13mm), 2665-1-15 (15mm).
Recalling Firm/
Abbott Spine
12708 Riata Vista Cir # B-100
Austin TX 78727-7167
Manufacturer Reason
for Recall
Tip of devices may dislodge while in use during surgery.
FDA Determined
Cause 2
Action All consignees that have the affected TraXis Fixed Rasps and TraXis Fixed Trials will be contacted via a documented phone script 11/07/2006. Affected inventory will be exchanged for re-worked instruments.
Quantity in Commerce 76 units.
Distribution Worldwide, including USA, Spain, Mexico, United Kingdom, Germany, and Cyprus
Total Product Life Cycle TPLC 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.