NA ANCHOR BOLT (REF ACS-030SMS-10)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03664539000688), received between Sep 29, 2026 and Sep 29, 2026 — classified as 1 injury.

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

9 other recalls cover devices cleared under the same FDA submission (K170959); 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. How this data works · Data updated Oct 13, 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.

• InjurySep 29, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928065 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170959. One submission often covers many models, so check the product and lot details in each record.

• Z-0537-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0534-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0538-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0535-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0540-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0539-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0541-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0542-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0536-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro