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Class 2 Device Recall TraXis Fixed Rasp |
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Date Initiated by Firm |
November 07, 2006 |
Date Posted |
January 17, 2007 |
Recall Status1 |
Terminated 3 on October 11, 2007 |
Recall Number |
Z-0355-2007 |
Recall Event ID |
36731 |
510(K)Number |
K060841
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Product Classification |
spinal impant - Product Code MQP
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Product |
TraXis Fixed Rasp in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; for use with TraXis vertebral body replacement system |
Code Information |
Part #2664-1-07 (7mm), 2664-1-09 (9mm), 2664-1-11 (11mm), 2664-1-13 (13mm), 2664-1-15 (15mm). |
Recalling Firm/ Manufacturer |
Abbott Spine 12708 Riata Vista Cir # B-100 Austin TX 78727-7167
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Manufacturer Reason for Recall |
Tip of devices may dislodge while in use during surgery.
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FDA Determined Cause 2 |
Other |
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 |
66 units. |
Distribution |
Worldwide, including USA, Spain, Mexico, United Kingdom, Germany, and Cyprus |
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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