Swish™ Straight Drill (6-16mmL) SPD3.2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10841307117391), received between Apr 9, 2018 and Sep 14, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (4 reports).

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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  PER COMPLAINT (B)(4), DURING RECEIVING INSPECTION, THE (B)(6) DISTRIBUTOR FOUND A LACK OF MATTED LASER MARKING TO SHOW 18 MM DEPTH ON THE SPD3.2 POWERED DENTAL DRILL. DISTRIBUTOR RECEIVED THE CORRECT PART, HOWEVER THEY RECEIVED THE PREVIOUS REVISION OF THIS DRILL WHICH IS NOW MARKETED WITH THE NEW GROOVINGS AND LASER MARKINGS. DISTRIBUTOR REQUESTED REPLACEMENTS WITH THE NEWEST REVISIONS. THERE WAS NO ADVERSE PATIENT EVENT ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 7879236 ↗
• MalfunctionSep 14, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  PER COMPLAINT (B)(4), DURING RECEIVING INSPECTION, THE (B)(4) DISTRIBUTOR FOUND A LACK OF MATTED LASER MARKING TO SHOW 18 MM DEPTH ON THE SPD3.2 POWERED DENTAL DRILL. DISTRIBUTOR RECEIVED THE CORRECT PART, HOWEVER THEY RECEIVED THE PREVIOUS REVISION OF THIS DRILL WHICH IS NOW MARKETED WITH THE NEW GROOVINGS AND LASER MARKINGS. DISTRIBUTOR REQUESTED REPLACEMENTS WITH THE NEWEST REVISIONS. THERE WAS NO ADVERSE PATIENT EVENT ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 7879233 ↗
• MalfunctionMay 3, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  (B)(4) DISTRIBUTOR FOUND DURING INCOMING INSPECTION, A LACK OF LASER MARKINGS. DISTRIBUTOR RECEIVED THE CORRECT PART, HOWEVER THEY RECEIVED THE PREVIOUS REVISION OF THIS DRILL WHICH IS NOW MARKETED WITH THE NEW GROOVINGS AND LASER MARKINGS. DISTRIBUTOR REQUESTED REPLACEMENTS WITH THE NEWEST REVISIONS.

  Patient problems: No Information

  MAUDE report 7485710 ↗
• MalfunctionApr 9, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  (B)(6) JAPAN DISTRIBUTOR FOUND DURING INCOMING INSPECTION, A LACK OF MATTED LASER MARKING IN ORDER TO SHOW 18 MM DEPTH ON A DRILL IN THE SWISH SYSTEM BASIC SURGICAL TRAY.

  Patient problems: No Patient Involvement

  MAUDE report 7406570 ↗

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