BioHorizons TLX3412Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Internal Implant, RBT, Laser-Lok, 3.4 x 12mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons Tapered Internal dental implant has 516 adverse event reports, with no deaths and 516 injuries. Most reports describe the implant failing to fuse with the bone, and some describe implants being 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
- 517
- Deaths reported
- 0
- Injuries reported
- 517
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 517 adverse event reports that list this exact device (DI 00847236010010), received between Feb 24, 2024 and Sep 30, 2026 — classified as 517 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (400 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate400
- Use of Device Problem135
- Loss of Osseointegration3
- Fracture2
- Compatibility Problem1
Patient problems
- Insufficient Information517
Recent adverse event reports
The 25 most recent of 517 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
InjurySep 21, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50834949 ↗InjurySep 16, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50788941 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50721746 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50643182 ↗InjuryAug 28, 2026Failure to Osseointegrate
InjuryAug 28, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50495607 ↗InjuryAug 14, 2026Failure to Osseointegrate
InjuryAug 12, 2026Failure to Osseointegrate
InjuryAug 6, 2026Failure to Osseointegrate
InjuryAug 6, 2026Failure to Osseointegrate
InjuryAug 6, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50157290 ↗InjuryAug 6, 2026Failure to Osseointegrate
InjuryAug 6, 2026Failure to Osseointegrate
InjuryAug 6, 2026Failure to Osseointegrate
InjuryJul 21, 2026Failure to Osseointegrate
InjuryJul 21, 2026Failure to Osseointegrate
InjuryJul 17, 2026Failure to Osseointegrate
InjuryJul 16, 2026Failure to Osseointegrate
InjuryJul 16, 2026Failure to Osseointegrate
InjuryJul 13, 2026Failure to Osseointegrate
InjuryJul 13, 2026Failure to Osseointegrate
InjuryJul 13, 2026Failure to Osseointegrate
InjuryJul 12, 2026Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25791545 ↗InjuryJul 9, 2026Use of Device Problem; Failure 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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