Z-1209-2009

KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland...

Name: Z-1209-2009 KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland...
Creator: Medtronic Spine LLC, formerly Kyphon Inc
Published: 2009-02-04
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2009-02-04 / Terminated / root cause: sterility

FDA source

Medtronic Spine LLC, formerly Kyphon Inc began a recall of KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland. For use in spinal surgery on 2009-02-04. The reason FDA records is "Product not sterile: 10 units were released for distribution without undergoing sterilization process". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1209-2009
Status: Terminated
Initiated: 2009-02-04
Posted: 2009-05-11
Terminated: 2009-07-14
Recalling firm: Medtronic, Inc.
Product: KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland. For use in spinal surgery.
Product code: HRX Arthroscope
Reason for recall: Product not sterile: 10 units were released for distribution without undergoing sterilization process.
Root cause tag: sterility
FDA 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 in commerce: 10 units affected.
Distribution: Product was distributed to two hospitals in OH and FL.
Product codes and lots: Catalog number K09A, Lot number 50000231, UPN 00858196001161.

Product code HRX

K041454Class IIKyphx Xpander Inflatable Bone Tamps Model#ko8a,ko9a,k13aKyphon, Inc. / cleared 2004-07-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)