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U.S. Department of Health and Human Services

Class 2 Device Recall Functional Anaesthetic Discography (F.A.D.) Catheter System

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  Class 2 Device Recall Functional Anaesthetic Discography (F.A.D.) Catheter System see related information
Date Initiated by Firm April 25, 2006
Date Posted February 05, 2008
Recall Status1 Terminated 3 on June 10, 2008
Recall Number Z-0948-2008
Recall Event ID 39366
510(K)Number K043500  
Product Classification Catheter System - Product Code BSP
Product Functional Anaesthetic Discography (F.A.D.) Catheter
System, Catalog #: D01A, Kyphon, Inc., Sunnyvale, Ca 94089
Code Information Lot Numbers: J6033012 and J6013102
Recalling Firm/
Kyphon Inc
1221 Crossman Ave
Sunnyvale CA 94089-1103
For Additional Information Contact Elizabeth Rothwell
Manufacturer Reason
for Recall
Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure.
FDA Determined
Cause 2
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 : J 6013102 = 147, Lot: J6033012 = 23
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.
510(K) Database 510(K)s with Product Code = BSP and Original Applicant = INNOSPINE, INC.