BioHorizons TRXP4612Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Platform Switch Implant, 4.6 x 12mm, RBT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a BioHorizons tapered dental implant, a screw-shaped root-form implant placed in the jawbone. Most of the reports describe the implant failing to fuse with the surrounding bone, so it does not become stable. There are 50 reports, all describing injuries, and no deaths. No recalls name this device. Reports in the past 12 months jumped from 9 to 35.
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
- 51
- Deaths reported
- 0
- Injuries reported
- 51
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00847236012762), received between Apr 17, 2024 and Sep 3, 2026 — classified as 51 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (49 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 Osseointegrate49
- Use of Device Problem2
Patient problems
- Insufficient Information51
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
InjurySep 3, 2026Failure to Osseointegrate
InjuryAug 17, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50280762 ↗InjuryAug 16, 2026Failure to Osseointegrate
InjuryAug 14, 2026Failure to Osseointegrate
InjuryAug 6, 2026Failure to Osseointegrate
InjuryJul 6, 2026Failure to Osseointegrate
InjuryJul 2, 2026Failure to Osseointegrate
InjuryJun 21, 2026Failure to Osseointegrate
InjuryJun 16, 2026Failure to Osseointegrate
InjuryJun 3, 2026Failure to Osseointegrate
InjuryMay 26, 2026Failure to Osseointegrate
InjuryMay 18, 2026Failure to Osseointegrate
InjuryMay 12, 2026Failure to Osseointegrate
InjuryApr 23, 2026Failure to Osseointegrate
InjuryApr 22, 2026Failure to Osseointegrate
InjuryApr 9, 2026Failure to Osseointegrate
InjuryApr 1, 2026Failure to Osseointegrate
InjuryApr 1, 2026Failure to Osseointegrate
InjuryApr 1, 2026Failure to Osseointegrate
InjuryFeb 17, 2026Failure to Osseointegrate
InjuryFeb 13, 2026Failure to Osseointegrate
InjuryFeb 13, 2026Failure to Osseointegrate
InjuryJan 28, 2026Failure to Osseointegrate
InjuryJan 9, 2026Failure to Osseointegrate
InjuryJan 5, 2026Failure 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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