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 pack Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 pack
Brand
Kyphon Inc
Lot Codes / Batch Numbers
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, Kyphon''s product removal only involved the two (2) additional lots of syringes, only portions of which were distributed to customers.
Products Sold
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.
Kyphon Inc is recalling KyphX Xpander brand Inflation Syringe; Merit Medical Part Number: K05-01290A. Kyphon Catalog Numb due to Devices for which sterility may be compromised as evidenced by a loss of package integrity.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Devices for which sterility may be compromised as evidenced by a loss of package integrity.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026