ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology 2316-0112-NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191375025832), received between Dec 29, 2024 and Dec 29, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K163269, K173535, 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.

• MalfunctionDec 29, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR DISC DEGENERATIVE DISEASE. PROCEDURE OR THERAPY PERFORMED WAS OLIF. LEVELS IMPLANTED L5/S1. IT WAS REPORTED THAT THE IMPLANT BROKE WHILE IT WAS IMPACTED WITH A METAL TAMP. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032123 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163269, K173535, K183557, K192018. One submission often covers many models, so check the product and lot details in each record.

• Z-0086-2022 · Sep 2, 2021 · Terminated
  Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
• 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