Functional Anaesthetic Discography (F.A.D.) Catheter System, Catalog #: D01A, Kyphon, Inc., Sunnyvale, Ca 94089
FDA device recall Z-0948-2008 · posted 2008-02-05 · Terminated
Recall details
- Recalling firm
- Kyphon Inc
- Reason for recall
- Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure.
- Action taken
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- BSP
- Quantity affected
- 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.
- Date initiated
- 2006-04-25
- Date posted
- 2008-02-05
- Date terminated
- 2008-06-10
- Location
- Sunnyvale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE (K043500) | Innospine, Inc. | 2005-04-15 |