FDA Medical Device Recalls (openFDA)
Kyphon Inc: KyphX Xpander brand Inflation Syringe; Merit Medical Part Number: K05-01290A. Kyphon Catalog Number: A08A. The medical device is distributed by Kyphon under the brand name KyphX Xpander Inflation Syringe. This medical device is provided as an individual stand-alone package (which also contains an accessory locking syringe device) and as an individually packaged component of the KyphoPak Tray. The Inflation Syringe packaging and contents are identical whether provided as a stand-alone package or as a component of the KyphoPak Tray.
- Recall number
- Z-0146-04
- Recalling firm
- Kyphon Inc
- Product
- KyphX Xpander brand Inflation Syringe; Merit Medical Part Number: K05-01290A. Kyphon Catalog Number: A08A. The medical device is distributed by Kyphon under the brand name KyphX Xpander Inflation Syringe. This medical device is provided as an individual stand-alone package (which also contains an accessory locking syringe device) and as an individually packaged component of the KyphoPak Tray. The Inflation Syringe packaging and contents are identical whether provided as a stand-alone package or as a component of the KyphoPak Tray.
- Status
- Terminated
- Initiated
- 2003-10-13
- Posted
- 2004-07-20
- Terminated
- 2004-03-08
- Reason
- Devices for which sterility may be compromised as evidenced by a loss of package integrity.
- Root cause
- Other
- Action
- On October 13, 2003, all consignees were notified via letter and on-site visit by a Kyphon sales representative, informing them of the affected devices and providing instructions on the recall.
- Quantity
- 211 syringes
- Distribution
- There were a total of 188 direct customers that received the recalled product distributed by Kyphon. There were 0 (zero) wholesaler dealers, distributors, retailers that received the recalled product distributed by Kyphon. The recalled product was distributed in the United States only. Recalled product was distributed by Kyphon to one VA hospital, VA Medical Center of San Diego, 3350 La Jolla Village Dr. San Diego, CA 92161. There were no shipments to foreign or Canadian distribution.
- Lot, serial or model codes
- Merit Medical (Inflation Syringe): Part No.: K05-01290A, Lot Nos.:A284998, A282736*; Kyphon (Inflation Syringe), Catalog No.: A08A, Lot Nos.: A284998, A282736. *Although Merit Medical''s notice of the recall involved three (3) lot numbers, one of the lots had already been returned by Kyphon to Merit Medical upon Kyphon''s discovery during incoming inspection that there was a problem with the packaging. So, Kyphon''s product removal only involved the two (2) additional lots of syringes, only portions of which were distributed to customers.
- 510(k) numbers
- ["K011811"]
- PMA numbers
- not on file
- Product code
- DXT
- Firm FEI
- 3004904811
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28