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U.S. Department of Health and Human Services

Class 2 Device Recall KyphX Xpander Inflatable Bone Tamp, size 15/3

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 Class 2 Device Recall KyphX Xpander Inflatable Bone Tamp, size 15/3see related information
Date Initiated by FirmFebruary 04, 2009
Date PostedMay 11, 2009
Recall Status1 Terminated 3 on July 14, 2009
Recall NumberZ-1209-2009
Recall Event ID 51206
510(K)NumberK041454 
Product Classification spinal bone tamp - Product Code HRX
ProductKyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland. For use in spinal surgery.
Code Information Catalog number K09A, Lot number 50000231, UPN 00858196001161.
Recalling Firm/
Manufacturer		 Medtronic Spine LLC, formerly Kyphon Inc
1221 Crossman Ave
Sunnyvale CA 94089-1103
For Additional Information Contact
408-548-6740
Manufacturer Reason
for Recall		Product not sterile: 10 units were released for distribution without undergoing sterilization process.
FDA Determined
Cause 2		Process change control
ActionSales 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 Commerce10 units affected.
DistributionProduct was distributed to two hospitals in OH and FL.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HRX
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