Class 2 Device Recall TraXis Vue Implant System

• Date Initiated by Firm: November 02, 2005
• Date Posted: February 07, 2006
• Recall Status: Terminated on September 25, 2007
• Recall Number: Z-0502-06
• Recall Event ID: 34014
• 510(K)Number: K031855
• Product Classification: Spinal Vertebral Body Replacement Device - Product Code MQP
• Product: TraXis Vue Spinal Implant System, Part #2601-090921
• Code Information: Lot #2010292
• FEI Number: 3000718496
• Recalling Firm/ Manufacturer: Abbott Spine; 12708 Riata Vista Cir # B-100; Austin TX 78727-7167
• Manufacturer Reason for Recall: Implants were manufactured without radiographic markers.
• FDA Determined Cause: Other
• Action: Firm initiated phone contact of all Sales Representatives who received lot and surgeons who have implanted lot on 11/02/05. Recall Letters to be sent to surgeons who have implanted affected lot.
• Quantity in Commerce: 41 units
• Distribution: Nationwide. Implants distributed to Sales Representatives in AZ, CA, FL, GA, KY, IL, MA, NY, OK, PA, TX, UT, VA and WI.
• 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.

• 510(K) Database: 510(K)s with Product Code = MQP