ENDOSKELETON® TC nanoLOCK® Surface Technology 5166-1406-NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191375013068), received between Oct 22, 2025 and Oct 22, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K141953, K183557, 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23354879 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141953, K183557, 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-0086-2022 · Sep 2, 2021 · Terminated
  Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
• 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
• 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