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ENDOSKELETON® TCS nanoLOCK® Surface Technology 5366-1410-NRecalls & reported problems

Medtronic Sofamor Danek, Inc. · Interbody Fusion Device 6 Degree Medium 10mm · Class 2 · Implant

All models of ENDOSKELETON TCS nanoLOCK Surface Technology (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (K153122, K173535, K183557, K191565, K192018); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Sep 2, 2021Class IITerminated

    Engraving on implants may not match what is listed on the pouch labels.

    Z-0086-2022 · Root cause: Packaging change control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153122, K173535, K183557, K191565, K192018. One submission often covers many models, so check the product and lot details in each record.

  • Z-0085-2022 · Sep 2, 2021 · Terminated
    Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
  • Z-1439-2021 · Mar 17, 2021 · Terminated
    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 f
  • Z-1440-2021 · Mar 17, 2021 · Terminated
    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 f

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page