KyphX Xpander brand Inflation Syringe; Merit Medical Part Number: K05-01290A. Kyphon Catalog Number: A08A. The medical d
FDA device recall Z-0146-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Kyphon Inc
- Reason for recall
- Devices for which sterility may be compromised as evidenced by a loss of package integrity.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXT
- Quantity affected
- 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
- Date initiated
- 2003-10-13
- Date posted
- 2004-07-20
- Date terminated
- 2004-03-08
- 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 |
|---|---|---|
| MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE (K011811) | Merit Medical Systems, Inc. | 2001-08-22 |