GoDirect® Implant 433711Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841307100300), received between Sep 25, 2019 and Aug 19, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 reports).

11 other recalls cover devices cleared under the same FDA submission (K090234); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2020Failure to Osseointegrate; Failure to Osseointegrate

  AS PER COMPLAINT (B)(4) DURING A CLINICAL PROCEDURE A DENTAL IMPLANT DISPLAYED A FAILURE OF OSSEOINTEGRATION AND THE IMPLANT WAS EXPLANTED. THERE WAS 1 PATIENT INVOLVED IN THIS EVENT.

  Patient problems: Edema; Failure of Implant; Inflammation; Pain

  MAUDE report 10426805 ↗
• InjurySep 25, 2019Device Appears to Trigger Rejection; Osseointegration Problem; Device Appears to Trigger Rejection; Osseointegration Problem

  PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.

  Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis

  MAUDE report 9115351 ↗
• InjurySep 25, 2019Device Appears to Trigger Rejection; Osseointegration Problem; Device Appears to Trigger Rejection; Osseointegration Problem

  PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.

  Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis

  MAUDE report 9115350 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090234. One submission often covers many models, so check the product and lot details in each record.

• Z-1157-2020 · Oct 11, 2019 · Terminated
  Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
• Z-1041-2020 · Oct 7, 2019 · Terminated
  Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
• Z-0364-2020 · Aug 9, 2019 · Terminated
  Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
• Z-0018-2020 · Aug 8, 2018 · Terminated
  ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The re
• Z-1167-2018 · Jan 19, 2018 · Terminated
  SwishTapered Implant Intended for use in support for fixed bridgework.
• Z-0185-2018 · Oct 10, 2017 · Terminated
  ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for
• Z-0007-2018 · Jul 21, 2017 · Terminated
  Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
• Z-1112-2017 · Dec 12, 2016 · Terminated
  SwishTapered Implant
• Z-0961-2017 · Nov 28, 2016 · Terminated
  GoDirect Screw-Retaining Top Part Numbers: 4500-61
• Z-1920-2018 · Nov 15, 2016 · Terminated
  ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
• Z-1267-2016 · Mar 4, 2016 · Terminated
  The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. GoDirect Implants Part Numbe