Medtronic Sofamor Danek, Prestige Cervical Disc System… recallZ-0141-2008 · Medtronic Sofamor Danek USA Inc · initiated Sep 4, 2007
Terminated All recalls posted in December 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Sofamor Danek USA Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0141-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 4, 2007
- Posted by the FDA
- Dec 19, 2007
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Quantity
- 196 units
- Product code
- MJO
- FDA submissions
- P060018
- Distribution
- Nationwide
Product description
Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972247, SIZE 7 X 14, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA
Code information (models, lots, serial numbers)
Lot Numbers: CN06M012, CN07A025, 434167, 510185, 511648, 510180, 511650, 510189, 515311, 513692, 521191, 523113, 421195 and 521188
Other devices under the same FDA submission
3 devices cleared under P060018 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PRESTIGE® Cervical Disc System 6961460Medtronic Sofamor Danek, Inc. · PROSTHESIS, INTERVERTEBRAL DISC6 reports
- PRESTIGE® Cervical Disc System 6961660Medtronic Sofamor Danek, Inc. · PROSTHESIS, INTERVERTEBRAL DISC1 report
- PRESTIGE® Cervical Disc System 6961470Medtronic Sofamor Danek, Inc. · PROSTHESIS, INTERVERTEBRAL DISC1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 44953).
- Z-0138-2008 · TerminatedMedtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972226, SIZE 6 X 12, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Te…
- Z-0139-2008 · TerminatedMedtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972246, SIZE 6 X 14, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, T…
- Z-0140-2008 · TerminatedMedtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972266, SIZE 6 X 16, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Te…
- Z-0142-2008 · TerminatedMedtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog: 6972267, SIZE 7 X 16, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Ten…
- Z-0143-2008 · TerminatedMedtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972287, SIZE 7 X 18, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, T…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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