FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek USA Inc: 8mm SATELLITE Sphere CoCr contained in a SATELLITE Spinal System (internal fixation device-vertebral stabilization/fusion)
- Recall number
- Z-1088-06
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Product
- 8mm SATELLITE Sphere CoCr contained in a SATELLITE Spinal System (internal fixation device-vertebral stabilization/fusion)
- Status
- Terminated
- Initiated
- 2006-01-14
- Posted
- 2006-06-08
- Terminated
- 2007-10-15
- Reason
- Device distribution without marketing clearance
- Root cause
- Other
- Action
- The recalling firm sent out a letter notifying the implanting surgeon that he had implanted a device that was not approved for use.
- Quantity
- 1 unit
- Distribution
- LA
- Lot, serial or model codes
- Cat No. 8000208, Lot No. W05K0555
- 510(k) numbers
- ["K051320"]
- PMA numbers
- not on file
- Product code
- MAX
- 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