BioHorizons TRXP3809Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Platform Switch Implant, 3.8 x 9mm, RBT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons TRXP3809 is a small tapered dental implant used as a tooth root replacement. The 29 reports all describe the same thing: the implant failing to fuse with the surrounding bone, so it does not stay anchored. All 29 involve an injury, and no deaths are reported. No recalls name this device. Reports have risen sharply, from 4 in the prior 12 months to 19 in the most recent 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
- 27
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00847236012694), received between Jul 11, 2024 and Jul 9, 2026 — classified as 27 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (27 reports).
1 other recall cover devices cleared under the same FDA submission (K121787, 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 Osseointegrate27
Patient problems
- Insufficient Information27
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2026Failure to Osseointegrate
InjuryJun 24, 2026Failure to Osseointegrate
InjuryMay 26, 2026Failure to Osseointegrate
InjuryMay 26, 2026Failure to Osseointegrate
InjuryMay 26, 2026Failure to Osseointegrate
InjuryApr 20, 2026Failure to Osseointegrate
InjuryApr 17, 2026Failure to Osseointegrate
InjuryMar 11, 2026Failure to Osseointegrate
InjuryMar 10, 2026Failure to Osseointegrate
InjuryMar 10, 2026Failure to Osseointegrate
InjuryFeb 23, 2026Failure to Osseointegrate
InjuryFeb 19, 2026Failure to Osseointegrate
InjuryFeb 17, 2026Failure to Osseointegrate
InjuryFeb 5, 2026Failure to Osseointegrate
InjuryJan 12, 2026Failure to Osseointegrate
InjuryDec 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 1, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
Recalls under the same FDA submission
These recalls involve devices cleared under K121787, 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
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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