FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog: 6972267, SIZE 7 X 16, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA
- Recall number
- Z-0142-2008
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Product
- Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog: 6972267, SIZE 7 X 16, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA
- Status
- Terminated
- Initiated
- 2007-09-04
- Posted
- 2007-12-19
- Terminated
- 2008-11-03
- Reason
- Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be imporperly seated.
- Root cause
- Device Design
- Action
- The firm notified their consignees of the problem and the recall by Urgent Medical Device Recall letter, telephone calls and electronic mail on 09/04/2007. Instructions include requests to immediately quarantine the product and hold for recalling firm collection.
- Quantity
- 196 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Numbers: CN07A034, CN07A031, 434185, 508110, 508111, 508108, 515701, 515702, 508112, 515686, 518409, 518410, 522181, 522179 and 522180
- 510(k) numbers
- not on file
- PMA numbers
- P060018
- Product code
- MJO
- 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
- 2026-10-14
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