FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1209-2009
- Recalling firm
- Medtronic Spine LLC, formerly Kyphon Inc
- Product
- KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland. For use in spinal surgery.
- Status
- Terminated
- Initiated
- 2009-02-04
- Posted
- 2009-05-11
- Terminated
- 2009-07-14
- 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.
- Lot, serial or model codes
- Catalog number K09A, Lot number 50000231, UPN 00858196001161.
- 510(k) numbers
- ["K041454"]
- PMA numbers
- not on file
- Product code
- HRX
- Firm FEI
- 3004904811
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28