BioHorizons TRXP3812Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Platform Switch Implant, 3.8 x 12mm, RBT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons tapered root-form dental implant is used as an anchor in the jawbone. The 28 reports describe the implant failing to fuse with the surrounding bone, with28 injuries and no deaths. Reports rose from 5 in the prior 12 months to 16 in the most recent 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
- 28
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00847236012717), received between Feb 28, 2024 and Sep 3, 2026 — classified as 28 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (24 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 Osseointegrate24
- Use of Device Problem5
Patient problems
- Insufficient Information28
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjurySep 3, 2026Failure to Osseointegrate
InjuryAug 14, 2026Failure to Osseointegrate
InjuryAug 14, 2026Failure to Osseointegrate
InjuryAug 12, 2026Failure to Osseointegrate
InjuryAug 12, 2026Failure to Osseointegrate
InjuryJun 25, 2026Failure to Osseointegrate
InjuryApr 27, 2026Failure to Osseointegrate
InjuryApr 22, 2026Failure to Osseointegrate
InjuryApr 22, 2026Failure to Osseointegrate
InjuryApr 22, 2026Failure to Osseointegrate
InjuryApr 22, 2026Failure to Osseointegrate
InjuryApr 8, 2026Failure to Osseointegrate
InjuryApr 6, 2026Failure to Osseointegrate
InjuryApr 6, 2026Failure to Osseointegrate
InjuryFeb 10, 2026Failure to Osseointegrate
InjuryNov 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 11, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22187868 ↗InjuryMay 9, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21997916 ↗InjuryJan 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 11, 2024Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 19088193 ↗
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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