Recall Z-1209-2009 ยท HRX Arthroscope
Medtronic Spine LLC, formerly Kyphon Inc
KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland. For use in spinal surgery.
| Date | May 11, 2009 (initiated Feb 4, 2009) |
| Status | Terminated |
| Reason | Product not sterile: 10 units were released for distribution without undergoing sterilization process. |
| Root cause | Process change control |
| Action | Sales representatives were contacted via e-mail on February 4, 2009, and instructed to contact hospitals and inform them of the issue and sequester affected product. They were further instructed to immediately travel to the hospitals and obtain affected product for return to Medtronic LLC. A Customer Communication Notice URGENT NOTICE: DEVICE REMOVAL dated February 9, 2009, was sent to the two consignees. |
| Quantity | 10 units affected. |
| Distribution | Product was distributed to two hospitals in OH and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041454 | KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A Kyphon, Inc., Jul 9, 2004 |