Medtronic Sofamor Danek Endoskeleton TCS Interbody System Recall: Label Mismatch Risk
Medtronic Sofamor Danek recalls Endoskeleton TCS Interbody System with Titan nanoLOCK Surface Technology due to possible mismatch between implant engraving and pouch labels. Affected units may require verification of labels before use.
Lower-risk recall
Engraving on implants may not match what is listed on the pouch labels.
Contact the company
What happened, in plain English
Medtronic Sofamor Danek is recalling a specific type of spinal implant system because the engraving on the implants might not match what's listed on the pouch labels. This mismatch could lead to incorrect implant selection during surgery, which might affect surgical outcomes. Read more at govinfonow.com/recall/61837-medtronic-sofamor-danek-endoskeleton-tcs-interbody-system-recall-label-mismatch.
Source Summary by GovInfoNow · govinfonow.com/recall/61837-medtronic-sofamor-danek-endoskeleton-tcs-interbody-system-recall-label-mismatch · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0086-2022
Cite this page
“Medtronic Sofamor Danek Endoskeleton TCS Interbody System Recall: Label Mismatch Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61837-medtronic-sofamor-danek-endoskeleton-tcs-interbody-system-recall-label-mismatch. Based on FDA recall #Z-0086-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0086-2022%22&limit=1).
Why it’s dangerous
The engraving on the implants may not match the labels on the pouches. This mismatch could cause surgeons to select the wrong implant size or type during surgery, potentially leading to complications.
Who’s affected
Patients who received this specific spinal implant system during surgery are likely affected. Surgeons and medical staff who use the product are at higher risk due to potential mislabeling.
How to tell if you have this one
Check for the product name 'Endoskeleton TCS Interbody System with Titan nanoLOCK Surface Technology', model 'NanoLock, 6 Deg, Interbody, Medium, 10mm', and product number 5366-1410-N. Lot A200510 and GTIN 00191375018490 are also identifiers for this recall.
- Brand
Medtronic Sofamor Danek- Product
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm- Category
Medical device
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
Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0085-2022 | Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm; Product Number 2312-0212-N, Lot A200323 GTIN 00191375014171 | 10 units |
| Z-0086-2022 | Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm; Product Number 5366-1410-N, Lot A200510 GTIN 00191375018490 | 9 units |
What to do — step by step
Verify Labels
Check that the engraving on the implant matches the labels on the pouch.
Where it went and when
Where it was distributed
Distributed in 14 states.
FDA distribution: “Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Minnesota, Missouri, Nevada, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Washington, West Virginia.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this recall dangerous?
The recall is for potential label mismatch, which could lead to incorrect implant selection during surgery. However, the hazard is not described as causing serious injury in normal use.
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Where this comes from
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-0086-2022 (September 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0086-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.