simply ReActive® Implant 754211URecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10841307108108), received between Feb 22, 2019 and Dec 29, 2022 — classified as 17 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2022Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 16066541 ↗
• InjurySep 26, 2022Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Fibrosis; Numbness; Osteopenia/ Osteoporosis; Sensitivity of Teeth

  MAUDE report 15483958 ↗
• InjuryMay 20, 2022Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Wound Dehiscence

  MAUDE report 14462272 ↗
• InjuryMay 20, 2022Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant

  MAUDE report 14462269 ↗
• InjuryFeb 3, 2022Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Unspecified Infection; Wound Dehiscence

  MAUDE report 13441449 ↗
• InjurySep 21, 2021Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Fibrosis; Granuloma; Inflammation; Unspecified Infection; Wound Dehiscence

  MAUDE report 12503662 ↗
• InjuryMay 7, 2021Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Wound Dehiscence

  MAUDE report 11789361 ↗
• InjuryMay 7, 2021Osseointegration Problem; Osseointegration Problem

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

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

  MAUDE report 11789321 ↗
• InjuryApr 9, 2021Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 11641415 ↗
• InjuryMar 26, 2021Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Fibrosis; Granuloma; Inflammation; Sinus Perforation

  MAUDE report 11574132 ↗
• InjurySep 25, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Pain; Unspecified Infection

  MAUDE report 10586615 ↗
• InjuryAug 7, 2020Failure to Osseointegrate; Failure to Osseointegrate

  AS PER COMPLAINT (B)(4) AFTER 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: Failure of Implant; Fibrosis; Inflammation; Osteopenia/ Osteoporosis; Unspecified Infection

  MAUDE report 10380359 ↗
• InjuryNov 13, 2019Osseointegration Problem; Osseointegration Problem

  PER COMPLAINT (B)(4), PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.

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

  MAUDE report 9314280 ↗
• InjuryOct 18, 2019Loss of Osseointegration; Loss of Osseointegration

  PER COMPLAINT (B)(4), PATIENT REPORTED WITH LOOSE CROWN. IMPLANT HAD FAILED TO INTEGRATE.

  Patient problems: Failure of Implant; No Information

  MAUDE report 9207947 ↗
• InjuryOct 1, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 9140112 ↗
• InjurySep 5, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

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

  MAUDE report 8963701 ↗
• InjuryFeb 22, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  PER COMPLAINT (B)(4), FOUR DAYS POST-OP MANDIBLE IMPLANT PLACEMENT, THE PATIENT PRESENTED WITH BURNING, INFLAMMATION, SLIGHT NUMBNESS AND PAIN SYMPTOMS. THE IMPLANT WAS BACKED OUT A FEW MILLIMETERS AND THE DOCTOR FOLLOWED UP THE NEXT DAY AND THE PATIENT FELT BETTER. ON (B)(6) 2019, THE PATIENT RETURNED INTO OFFICE WITH CONTINUED ISSUES AND THE IMPLANT WAS EXTRACTED. THE PATIENT WAS PLACED ON MEDROL DOSE PACK POST-OP IMPLANT REMOVAL.

  Patient problems: Burning Sensation; Inflammation; Numbness; Pain

  MAUDE report 8363582 ↗

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