Z-0146-04

KyphX Xpander brand Inflation Syringe; Merit Medical Part Number: K05-01290A. Kyphon Catalog Number: A08A...

Name: Z-0146-04 KyphX Xpander brand Inflation Syringe; Merit Medical Part Number: K05-01290A. Kyphon Catalog Number: A08A...
Creator: Kyphon Inc
Published: 2003-10-13
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2003-10-13 / Terminated / root cause: packaging

FDA source

Kyphon Inc began a recall of KyphX Xpander brand Inflation Syringe; Merit Medical Part Number: K05-01290A. Kyphon Catalog Number: A08A. The medical device is distributed by Kyphon under... on 2003-10-13. The reason FDA records is "Devices for which sterility may be compromised as evidenced by a loss of package integrity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0146-04
Status: Terminated
Initiated: 2003-10-13
Posted: 2004-07-20
Terminated: 2004-03-08
Recalling firm: Medtronic, 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.
Product code: DXT Injector And Syringe, Angiographic
Reason for recall: Devices for which sterility may be compromised as evidenced by a loss of package integrity.
Root cause tag: packaging
FDA 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 in commerce: 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.
Product codes and lots: 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.

Product code DXT

K011811Class IIMonarch Inflation Syringe; Universal Fluid Dispensing SyringeMerit Medical Systems, Inc. / cleared 2001-08-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)