FDA Recall
Terminated
KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland. For use in spinal surgery.
Recall: Z-1209-2009
·
Initiated February 4, 2009
Recall
- Recall Number
- Z-1209-2009
- Event Number
- 51206
- Firm
- Medtronic Spine LLC, formerly Kyphon Inc
- FEI Number
- 3004904811
- Product Code
- HRX
- Status
- Terminated
- Root Cause
- Process change control
- Initiated
- February 4, 2009
- Posted
- May 11, 2009
- Terminated
- July 14, 2009
- Address
- 1221 Crossman Ave, Sunnyvale, CA, 94089-1103
Description
KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland. For use in spinal surgery.
Reason
Product not sterile: 10 units were released for distribution without undergoing sterilization process.
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.
Distribution
Product was distributed to two hospitals in OH and FL.
Quantity
10 units affected.