BioHorizons TRX4615Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Internal Implant, 4.6 x 15mm, Mountless, RBT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons tapered dental implant is intended to anchor a tooth replacement in the jawbone. Reports mostly describe the implant failing to bond with the bone; one mentions removal shortly after placement for surgical reasons. There are 26 reports, with 26 injuries and no deaths. No recalls name this device; reports increased from 3 in the previous 12 months to 11 in the latest 12 months.
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
- 24
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00847236000585), received between Feb 24, 2024 and Jul 6, 2026 — classified as 24 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (23 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 Osseointegrate23
- Use of Device Problem2
- Loss of Osseointegration1
Patient problems
- Insufficient Information24
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryJul 6, 2026Failure to Osseointegrate
InjuryMar 17, 2026Failure to Osseointegrate
InjuryFeb 25, 2026Failure to Osseointegrate
InjuryFeb 25, 2026Failure to Osseointegrate
InjuryFeb 25, 2026Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24446600 ↗InjuryDec 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 13, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22206305 ↗InjuryMay 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 24, 2024Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration
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.
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