BioHorizons TRX4612Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Internal Implant, 4.6 x 12mm, Mountless, RBT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons Tapered Internal dental implant has 231 adverse event reports, including 231 injuries and no deaths. The reports mostly describe the implant failing to bond with the bone, with little patient information included. Reports rose from 67 in the previous 12 months to 113 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
- 238
- Deaths reported
- 0
- Injuries reported
- 238
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 238 adverse event reports that list this exact device (DI 00847236000578), received between Feb 15, 2024 and Sep 30, 2026 — classified as 238 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (225 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. 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 Osseointegrate225
- Use of Device Problem18
- Fracture1
- Loss of Osseointegration1
Patient problems
- Insufficient Information238
Recent adverse event reports
The 25 most recent of 238 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
InjurySep 21, 2026Failure to Osseointegrate
InjurySep 21, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50834945 ↗InjurySep 14, 2026Failure to Osseointegrate
InjurySep 10, 2026Failure to Osseointegrate
InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50643173 ↗InjuryAug 31, 2026Failure to Osseointegrate
InjuryAug 25, 2026Failure to Osseointegrate
InjuryAug 24, 2026Failure to Osseointegrate
InjuryAug 19, 2026Failure to Osseointegrate
InjuryAug 16, 2026Failure to Osseointegrate
InjuryAug 12, 2026Failure to Osseointegrate
InjuryAug 6, 2026Failure to Osseointegrate
InjuryAug 5, 2026Failure to Osseointegrate
InjuryAug 5, 2026Failure to Osseointegrate
InjuryAug 5, 2026Failure to Osseointegrate
InjuryAug 5, 2026Failure to Osseointegrate
InjuryJul 12, 2026Failure to Osseointegrate
InjuryJul 12, 2026Failure to Osseointegrate
InjuryJul 10, 2026Failure to Osseointegrate
InjuryJul 8, 2026Failure to Osseointegrate
InjuryJul 7, 2026Failure to Osseointegrate
InjuryJul 6, 2026Failure to Osseointegrate
InjuryJul 1, 2026Failure to Osseointegrate
InjuryJul 1, 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 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