ReActive® Implant 754210Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø3.7 x 8 Platform 3.5mmD · Class 2 · Implant
All models of ReActive Implant (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Implant Direct ReActive dental implant is a screw-shaped post placed in the jawbone. Most of the 82 reports describe the implant failing to bond with the jawbone, and some describe poor positioning. The reports include 82 injuries and no deaths, and reports fell from 14 in the previous 12 months to 2 in the last 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 82
- Deaths reported
- 0
- Injuries reported
- 82
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10841307103646), received between Aug 8, 2019 and Mar 3, 2026 — classified as 82 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (48 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate48
- Positioning Failure13
- Component Incompatible7
- Loss of Osseointegration7
- Osseointegration Problem7
- Positioning Problem2
Patient problems
- Failure of Implant74
- Inflammation18
- Osteopenia/ Osteoporosis14
- No Consequences Or Impact To Patient9
- No Clinical Signs, Symptoms or Conditions8
- Inadequate Osseointegration7
- Insufficient Information6
- Granuloma5
Recent adverse event reports
The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.
InjuryMar 3, 2026Component Incompatible
FAILURE TO OSSEOINTEGRATE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24501940 ↗InjuryFeb 18, 2026Component Incompatible
FAILURE OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24384052 ↗InjuryOct 31, 2025Component Incompatible; Failure to Osseointegrate; Component Incompatible; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23436809 ↗InjuryOct 31, 2025Component Incompatible; Failure to Osseointegrate; Component Incompatible; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23436803 ↗InjuryMar 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21714041 ↗InjuryFeb 7, 2025Component Incompatible; Component Incompatible
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21338322 ↗InjuryFeb 7, 2025Component Incompatible; Component Incompatible
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21338317 ↗InjuryDec 10, 2024Positioning Failure; Positioning Failure
InjuryDec 10, 2024Positioning Failure; Positioning Failure
InjuryDec 10, 2024Positioning Failure; Positioning Failure
InjuryDec 9, 2024Positioning Failure; Positioning Failure
InjuryDec 9, 2024Positioning Failure; Positioning Failure
InjuryDec 6, 2024Positioning Failure; Positioning Failure
InjuryDec 6, 2024Positioning Failure; Positioning Failure
InjuryDec 6, 2024Positioning Failure; Positioning Failure
InjuryDec 6, 2024Component Incompatible; Component Incompatible
InjuryOct 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRODUCT COMPL: FAILURE TO OSSEOINTEGRATE
Patient problems: Failure of Implant; Implant Pain
MAUDE report 20499317 ↗InjuryAug 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19902014 ↗InjuryApr 23, 2024Osseointegration Problem; Osseointegration Problem
InjuryApr 20, 2024Osseointegration Problem; Osseointegration Problem
InjuryApr 1, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Bone Fracture(s); Failure of Implant
MAUDE report 19014635 ↗
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 · TerminatedImplant 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 · TerminatedLegacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
- Z-0364-2020 · Aug 9, 2019 · TerminatedImplant 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 · TerminatedImplantDirect 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 resp
- Z-1167-2018 · Jan 19, 2018 · TerminatedSwishTapered Implant Intended for use in support for fixed bridgework.
- Z-0185-2018 · Oct 10, 2017 · TerminatedImplantDirect 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 · TerminatedImplant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
- Z-1112-2017 · Dec 12, 2016 · TerminatedSwishTapered Implant
- Z-0961-2017 · Nov 28, 2016 · TerminatedGoDirect Screw-Retaining Top Part Numbers: 4500-61
- Z-1920-2018 · Nov 15, 2016 · TerminatedImplantDirect 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 · TerminatedThe 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
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page