BioHorizons TRX4609Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Internal Implant, 4.6 x 9mm, Mountless, RBT · Class 2 · Implant
Quick summary
This BioHorizons tapered dental implant has 324 reports, all injuries, and no deaths. Most describe the implant failing to bond with the jawbone. No recalls name this device. Reports rose to 174 in the last 12 months from 96 in the 12 months before.
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
- 340
- Deaths reported
- 0
- Injuries reported
- 340
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 340 adverse event reports that list this exact device (DI 00847236000554), received between Feb 15, 2024 and Sep 30, 2026 — classified as 340 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (327 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 Osseointegrate327
- Use of Device Problem16
- Osseointegration Problem1
Patient problems
- Insufficient Information340
Recent adverse event reports
The 25 most recent of 340 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50950041 ↗InjurySep 30, 2026Failure to Osseointegrate
InjurySep 30, 2026Failure to Osseointegrate
InjurySep 29, 2026Failure to Osseointegrate
InjurySep 28, 2026Failure to Osseointegrate
InjurySep 21, 2026Failure to Osseointegrate
InjurySep 21, 2026Failure to Osseointegrate
InjurySep 21, 2026Failure to Osseointegrate
InjurySep 21, 2026Failure to Osseointegrate
InjurySep 21, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50834955 ↗InjurySep 17, 2026Failure to Osseointegrate
InjurySep 15, 2026Failure to Osseointegrate
InjurySep 15, 2026Failure to Osseointegrate
InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50741873 ↗InjurySep 8, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50679440 ↗InjurySep 8, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50679434 ↗InjuryAug 31, 2026Failure to Osseointegrate
InjuryAug 31, 2026Failure to Osseointegrate
InjuryAug 28, 2026Failure to Osseointegrate
InjuryAug 25, 2026Failure to Osseointegrate
InjuryAug 25, 2026Failure to Osseointegrate
InjuryAug 16, 2026Failure to Osseointegrate
InjuryAug 16, 2026Failure to Osseointegrate
InjuryAug 14, 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.