Recall Z-0949-2008 ยท BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Kyphon Inc
Kyphon, Functional Anaesthetic Discography (F.A.D.) Introducer Needle, Catalog Number: D01B, 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 : J6013101 = 150, Lot: J6033011 = 43 |
| 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
This recall record lists no 510(k) number.