FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek USA Inc: Colorado 2 Spinal System, Anterior Plate, REF8619500, for export only, manufactured at: Warsaw, Indiana USA, Rx only
- Recall number
- Z-0654-2007
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Product
- Colorado 2 Spinal System, Anterior Plate, REF8619500, for export only, manufactured at: Warsaw, Indiana USA, Rx only
- Status
- Terminated
- Initiated
- 2007-02-02
- Posted
- 2007-03-27
- Terminated
- 2007-08-11
- Reason
- Bone screws may pull though the plate.
- Root cause
- Other
- Action
- Medtronic Global Quality initiated the recall via letter on 02/02/2007. Sub-recalls will be managed by Medtronic EMEA quality (Europe, Middle East, and Africa) in the affected geographies. Distributors and surgical facilities will be contacted as well as regulatory bodies in each country.
- Quantity
- 293 units
- Distribution
- France, Germany, Italy, UK, and Tunisia. No US distribution.
- Lot, serial or model codes
- Lot Nos.: W04E0149, W04C1938, 553880, 672660, 353150, 355610, 201190, 198840, 947250, 914870, 82549, 81749, 81320, 76967, 65867, 42841, 42842.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KWQ
- 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