BioHorizons TLX3415Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Internal Implant, RBT, Laser-Lok, 3.4 x 15mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons tapered internal dental implant is a root-form implant placed into bone. Its 151 adverse event reports are all listed as injuries, with no deaths, and most describe implants that failed to fuse with the bone, with some removed soon after placement. 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
- 150
- Deaths reported
- 0
- Injuries reported
- 150
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 150 adverse event reports that list this exact device (DI 00847236010027), received between Feb 27, 2024 and Sep 21, 2026 — classified as 150 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (111 reports).
1 other recall cover devices cleared under the same FDA submission (K143022, K223697); 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 Osseointegrate111
- Use of Device Problem42
- Fracture1
- Osseointegration Problem1
Patient problems
- Insufficient Information150
Recent adverse event reports
The 25 most recent of 150 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50834964 ↗InjuryAug 11, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50211505 ↗InjuryAug 11, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50211387 ↗InjuryJul 12, 2026Failure to Osseointegrate
InjuryJul 6, 2026Failure to Osseointegrate
InjuryJul 6, 2026Failure to Osseointegrate
InjuryJun 29, 2026Use of Device Problem; Failure to Osseointegrate
InjuryJun 21, 2026Failure to Osseointegrate
InjuryJun 8, 2026Failure to Osseointegrate
InjuryJun 2, 2026Failure to Osseointegrate
InjuryJun 2, 2026Failure to Osseointegrate
InjuryMay 29, 2026Failure to Osseointegrate
InjuryMay 12, 2026Failure to Osseointegrate
InjuryMay 4, 2026Failure to Osseointegrate
InjuryApr 2, 2026Fracture; Failure to Osseointegrate
InjuryApr 2, 2026Failure to Osseointegrate
InjuryFeb 27, 2026Failure to Osseointegrate
InjuryFeb 24, 2026Failure to Osseointegrate
InjuryFeb 17, 2026Failure to Osseointegrate
InjuryFeb 6, 2026Failure to Osseointegrate
InjuryFeb 2, 2026Failure to Osseointegrate
InjuryJan 20, 2026Failure to Osseointegrate
InjuryJan 16, 2026Failure to Osseointegrate
InjuryJan 15, 2026Failure to Osseointegrate
InjuryJan 12, 2026Failure to Osseointegrate
Recalls under the same FDA submission
These recalls involve devices cleared under K143022, K223697. One submission often covers many models, so check the product and lot details in each record.
- Z-1111-2025 · Dec 6, 2024 · Open, ClassifiedTemporary Titanium Abutments
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