Medtronic recalls Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology due to shelf box mislabeling. This may cause confusion about device size. No immediate action needed.
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.
“Medtronic Endoskeleton TC Interbody System: Shelf Box Mislabeling Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/63043-medtronic-endoskeleton-tc-interbody-system-shelf-box-mislabeling-risk. Based on FDA recall #Z-1440-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1440-2021%22&limit=1).
The FDA announced on March 17, 2021, that Medtronic Sofamor Danek USA Inc is recalling the Endoskeleton TC Interbody System due to a labeling error where small and large devices are swapped in their packaging. This Class II recall affects 11 units distributed nationwide.
How to tell if you have it
Brand: Medtronic Sofamor Danek USA, Inc
Product: Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm
Product Number: 5146-1608-N
UPC: 00191375013167
Lot Number: TM0126572
The hazard
The hazard involves a mismatch between the shelf box label and the actual device inside; boxes labeled for small devices contain large ones, and vice versa. This mislabeling poses a risk of using the incorrect device size during surgical procedures.
Context
GovInfoNow's records show Medtronic Sofamor Danek USA Inc has issued 19 other recalls since December 6, 2017. Recent brand recalls include an expandable interbody system cage recall on September 16, 2025, and a Grafton DMB Matrix recall for a Tyvek pouch inspection issue on September 26, 2023. Other recent recalls of similar products include the XTANT Medical Xpress Pedicle Screw System (February 18, 2026), Micro Therapeutics Pipeline Flex Embolization Device (June 8, 2026), and Encore Medical EMPOWR 3D KNEE Ins 11L 14MM VE (February 16, 2026).
How to tell if you have this one
Check for the product number 5146-1608-N on the shelf box. The device is sold with GTIN 00191375013167 and lot number TM0126572.
Brand
Medtr: a short, human brand name for headings (e.g.
Product
Medtronic Sofamor Danek USA, Inc recalls Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide distribution.
Recall number
Product, codes & lots
Z-1439-2021
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-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.; GTIN 00191375013006, Lot Number TM0126527
Z-1440-2021
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.; GTIN 00191375013167, Lot Number TM0126572
Based on the official FDA remedy
What to do — step by step
Check Product Labels
Look for the product number 5146-1608-N on the shelf box to confirm the device.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1440-2021 (March 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1440-2021 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.