FDA Medical Device Recalls (openFDA)
Kyphon Inc: Kyphon, Functional Anaesthetic Discography (F.A.D.) Introducer Needle, Catalog Number: D01B, Kyphon, Inc., Sunnyvale, Ca 94089
- Recall number
- Z-0949-2008
- Recalling firm
- Kyphon Inc
- Product
- Kyphon, Functional Anaesthetic Discography (F.A.D.) Introducer Needle, Catalog Number: D01B, Kyphon, Inc., Sunnyvale, Ca 94089
- Status
- Terminated
- Initiated
- 2006-04-25
- Posted
- 2008-02-05
- Terminated
- 2008-06-10
- Reason
- Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure.
- Root 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
- 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.
- Lot, serial or model codes
- Lot Number : J6033011 and Lot Number : J6013101
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BSP
- Firm FEI
- 3004904811
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28