Class 2 Device Recall TraXis Fixed Trial

• Date Initiated by Firm: November 07, 2006
• Date Posted: January 17, 2007
• Recall Status: Terminated 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/ Manufacturer: 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: 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: 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.