Kyphon Inc Kyphon, Functional Anaesthetic Discography (F.A.D.) Introducer Needle, Catalog Number: D01B, Kyphon, Inc., Sunnyvale, Ca 94089 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Kyphon, Functional Anaesthetic Discography (F.A.D.) Introducer Needle, Catalog Number: D01B, Kyphon, Inc., Sunnyvale, Ca 94089
Brand
Kyphon Inc
Lot Codes / Batch Numbers
Lot Number : J6033011 and Lot Number : J6013101
Products Sold
Lot Number : J6033011 and Lot Number : J6013101
Kyphon Inc is recalling Kyphon, Functional Anaesthetic Discography (F.A.D.) Introducer Needle, Catalog Number: D01B, Kyphon, due to Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026