FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek USA Inc: KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.
- Recall number
- Z-1057-2015
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Product
- KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.
- Status
- Terminated
- Initiated
- 2015-01-13
- Posted
- 2015-02-05
- Terminated
- 2015-07-13
- Reason
- The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two diamond-tipped instruments.
- Root cause
- Process control
- Action
- On January 12, 2015, the Sales Managers and Sales Force were notified by Post-Market Quality regarding the imminent notification and follow-up activities. The recall notices were delivered to the Risk Managers at impacted consignee sites on January 13, 2015. These recall notices included a Risk Manager Letter informing them on the action, and a consignee-specific questionnaire to indicate their product on-hand.
- Quantity
- 239 units
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- WI14H054
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LYQ
- Firm FEI
- 1000477302
- Firm city
- Memphis
- Firm state
- TN
- 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