Class 2 Device Recall Functional Anaesthetic Discography (F.A.D.) Introducer Needle

• Date Initiated by Firm: April 25, 2006
• Date Posted: February 05, 2008
• Recall Status: Terminated on June 10, 2008
• Recall Number: Z-0949-2008
• Recall Event ID: 39366
• Product Classification: Introducer Needle-Catheter System - Product Code BSP
• Product: Kyphon, Functional Anaesthetic Discography (F.A.D.) Introducer Needle, Catalog Number: D01B, Kyphon, Inc., Sunnyvale, Ca 94089
• Code Information: Lot Number : J6033011 and Lot Number : J6013101
• Recalling Firm/ Manufacturer: Kyphon Inc; 1221 Crossman Ave; Sunnyvale CA 94089-1103
• For Additional Information Contact: Elizabeth Rothwell; 408-548-6500
• Manufacturer Reason for Recall: Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure.
• FDA Determined Cause: Labeling design
• Action: A customer advisory letter was sent on 4/25/06 to consignees. In some cases some were issued in person. Follow up with field representatives was also conducted. Both contacts involved providing IMPORTANT CHANGES IN INSTRUCTIONS FOR USE that are to be attached to the on site users documents. The recalling firm is updating future distribution with the new instructions for use.
• Quantity in Commerce: By Lot Number : J6013101 = 150, Lot: J6033011 = 43
• Distribution: Nationwide including states of AL, AZ, CA, FL, IN, NH, NY, DC, ME, MD, WI, and PA.
• 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.