Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology Recalled by Medtronic Sofamor Danek USA, Inc Due to The shelf box identifies a small device actually...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Sofamor Danek USA, Inc directly.
Affected Products
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.
Quantity: 11 devices
Why Was This Recalled?
The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Sofamor Danek USA, Inc
Medtronic Sofamor Danek USA, Inc has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report