BioHorizons TLX4609Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Internal Implant, 4.6 x 9mm, Mountless, RBT+Laser-Lok · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons Tapered Internal implant, placed into bone, has 337 reports, all of them injuries, and no deaths. The reports mostly describe the implant not bonding with the surrounding bone, and every report lacks patient detail. 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
- 342
- Deaths reported
- 0
- Injuries reported
- 342
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 342 adverse event reports that list this exact device (DI 00847236010096), received between Feb 21, 2024 and Sep 30, 2026 — classified as 342 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (298 reports).
2 other recalls cover devices cleared under the same FDA submission (K071638, 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 Osseointegrate298
- Use of Device Problem49
- Loss of Osseointegration5
- Fracture1
Patient problems
- Insufficient Information342
Recent adverse event reports
The 25 most recent of 342 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50950079 ↗InjurySep 30, 2026Failure to Osseointegrate
InjurySep 28, 2026Failure to Osseointegrate
InjurySep 28, 2026Failure to Osseointegrate
InjurySep 21, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50834940 ↗InjurySep 16, 2026Failure to Osseointegrate
InjurySep 16, 2026Failure to Osseointegrate
InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50741715 ↗InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50715008 ↗InjurySep 6, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50637048 ↗InjurySep 6, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50637045 ↗InjuryAug 31, 2026Failure to Osseointegrate
InjuryAug 31, 2026Failure to Osseointegrate
InjuryAug 25, 2026Failure to Osseointegrate
InjuryAug 25, 2026Failure to Osseointegrate
InjuryAug 16, 2026Failure to Osseointegrate
InjuryAug 14, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50257325 ↗InjuryAug 14, 2026Failure to Osseointegrate
InjuryAug 11, 2026Failure to Osseointegrate
InjuryAug 11, 2026Failure to Osseointegrate
InjuryAug 10, 2026Failure to Osseointegrate
InjuryAug 9, 2026Failure to Osseointegrate
InjuryAug 9, 2026Failure to Osseointegrate
InjuryAug 7, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50181498 ↗InjuryAug 5, 2026Failure to Osseointegrate
Recalls under the same FDA submission
These recalls involve devices cleared under K071638, 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
- Z-1605-2015 · Apr 16, 2015 · TerminatedTapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
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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