SwishPlus® Implant 924814Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10841307106227), received between Dec 18, 2017 and Aug 19, 2022 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2022Osseointegration Problem; Osseointegration Problem

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant; Inflammation

  MAUDE report 15258714 ↗
• MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.

  Patient problems: Not Applicable

  MAUDE report 7125826 ↗
• MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.

  Patient problems: Not Applicable

  MAUDE report 7125824 ↗
• MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.

  Patient problems: Not Applicable

  MAUDE report 7125823 ↗
• MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.

  Patient problems: Not Applicable

  MAUDE report 7125821 ↗
• MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.

  Patient problems: Not Applicable

  MAUDE report 7125793 ↗
• MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.

  Patient problems: Not Applicable

  MAUDE report 7125787 ↗
• MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.

  Patient problems: Not Applicable

  MAUDE report 7125762 ↗
• MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED..

  Patient problems: Not Applicable

  MAUDE report 7125757 ↗
• MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.

  Patient problems: Not Applicable

  MAUDE report 7125719 ↗
• MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.

  Patient problems: Not Applicable

  MAUDE report 7125714 ↗

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