Date Initiated by Firm |
February 04, 2009 |
Date Posted |
May 11, 2009 |
Recall Status1 |
Terminated 3 on July 14, 2009 |
Recall Number |
Z-1209-2009 |
Recall Event ID |
51206 |
510(K)Number |
K041454
|
Product Classification |
spinal bone tamp - Product Code HRX
|
Product |
KyphX 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 |
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. |
Total Product Life Cycle |
TPLC Device Report
|
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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) Database |
510(K)s with Product Code = HRX and Original Applicant = KYPHON, INC.
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