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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland. For use in spinal surgery.
Brand
Medtronic Spine LLC, formerly Kyphon Inc
Lot Codes / Batch Numbers
Catalog number K09A, Lot number 50000231, UPN 00858196001161.
Products Sold
Catalog number K09A, Lot number 50000231, UPN 00858196001161.
Medtronic Spine LLC, formerly Kyphon Inc is recalling KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Swi due to Product not sterile: 10 units were released for distribution without undergoing sterilization process.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product not sterile: 10 units were released for distribution without undergoing sterilization process.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, IN, OH
Page updated: Jan 10, 2026