BioHorizons TRX5807Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Internal Implant, 5.8 x 7.5mm, Mountless, RBT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons TRX5807 is a tapered internal dental implant used as a root replacement in the jaw. The 48 reports almost all describe the same thing: the implant failing to fuse with the surrounding bone, so it does not become stable. All 48 reports involve injuries, with no deaths, and 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
- 48
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00847236000592), received between Feb 24, 2024 and Aug 28, 2026 — classified as 48 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (46 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 Osseointegrate46
- Use of Device Problem3
- Loss of Osseointegration1
Patient problems
- Insufficient Information48
- Alteration in Body Temperature1
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2026Failure to Osseointegrate
InjuryAug 9, 2026Failure to Osseointegrate
InjuryMay 24, 2026Failure to Osseointegrate
InjuryMay 12, 2026Failure to Osseointegrate
InjuryApr 10, 2026Failure to Osseointegrate
InjuryMar 19, 2026Failure to Osseointegrate
InjuryMar 15, 2026Failure to Osseointegrate
InjuryMar 15, 2026Failure to Osseointegrate
InjuryMar 12, 2026Failure to Osseointegrate
InjuryMar 12, 2026Failure to Osseointegrate
InjuryJan 23, 2026Failure to Osseointegrate
InjuryJan 12, 2026Failure to Osseointegrate
InjuryDec 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 14, 2025Use of Device Problem; Failure to Osseointegrate; Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22804441 ↗InjuryMay 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 5, 2025Failure to Osseointegrate; Failure 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.
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