Step Drill (6-16mml) SD2.8Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841307117155), received between Nov 6, 2019 and Nov 6, 2019 — classified as 1 malfunction.

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

3 other recalls cover devices cleared under the same FDA submission (K081396); 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.

• MalfunctionNov 6, 2019Separation Failure; Separation Failure

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE IT WAS OBSERVED THAT THE COMPONENTS COULD NOT BE SEPARATED.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 9283247 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081396. One submission often covers many models, so check the product and lot details in each record.

• Z-1126-2020 · Jan 9, 2019 · Terminated
  SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
• Z-1168-2018 · Jan 19, 2018 · Terminated
  SwishPlus Implant Intended for use in support for fixed bridgework.
• Z-0396-2016 · Oct 28, 2015 · Terminated
  DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable