FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution: Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
- Recall number
- Z-0321-2016
- Recalling firm
- Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
- Product
- Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
- Status
- Terminated
- Initiated
- 2015-10-21
- Posted
- not on file
- Terminated
- 2016-06-24
- Reason
- The wire pass hole is not present on the tools.
- Root cause
- Process control
- Action
- A recall letter was mailed to consignees on October 21, 2015.
- Quantity
- 9 pieces
- Distribution
- Distributed in the states of California, New York, and Texas and the country of Belgium.
- Lot, serial or model codes
- Catalog Number: 16TA24, Lot Number: 0006936810
- 510(k) numbers
- ["K020069"]
- PMA numbers
- not on file
- Product code
- HBB
- Firm FEI
- 1625507
- Firm city
- Haltom City
- Firm state
- TX
- 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