Recall Z-0948-2008 ยท BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Kyphon Inc
Functional Anaesthetic Discography (F.A.D.) Catheter System, Catalog #: D01A, Kyphon, Inc., Sunnyvale, Ca 94089
| Date | Feb 5, 2008 (initiated Apr 25, 2006) |
| Status | Terminated |
| 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 : J 6013102 = 147, Lot: J6033012 = 23 |
| Distribution | Nationwide including states of AL, AZ, CA, FL, IN, NH, NY, DC, ME, MD, WI, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043500 | FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE Innospine, Inc., Apr 15, 2005 |