KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland. For use in
FDA device recall Z-1209-2009 · posted 2009-05-11 · Terminated
Recall details
- Recalling firm
- Medtronic Spine LLC, formerly Kyphon Inc
- Reason for recall
- Product not sterile: 10 units were released for distribution without undergoing sterilization process.
- Action taken
- 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.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 10 units affected.
- Distribution
- Product was distributed to two hospitals in OH and FL.
- Date initiated
- 2009-02-04
- Date posted
- 2009-05-11
- Date terminated
- 2009-07-14
- Location
- Sunnyvale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A (K041454) | Kyphon, Inc. | 2004-07-09 |