BioHorizons TRXP4609Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Platform Switch Implant, 4.6 x 9mm, RBT · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons tapered dental implant has 110 adverse event reports, with no deaths and 110 injuries. Most reports describe the implant failing to bond with the jawbone. Reports rose to 66 in the last 12 months from 21 in the 12 months before. 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
- 110
- Deaths reported
- 0
- Injuries reported
- 110
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 00847236012748), received between Mar 15, 2024 and Sep 14, 2026 — classified as 110 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (106 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate106
- Use of Device Problem7
Patient problems
- Insufficient Information110
Recent adverse event reports
The 25 most recent of 110 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Failure to Osseointegrate
InjurySep 10, 2026Failure to Osseointegrate
InjurySep 10, 2026Failure to Osseointegrate
InjuryAug 28, 2026Failure to Osseointegrate
InjuryAug 18, 2026Failure to Osseointegrate
InjuryAug 17, 2026Failure to Osseointegrate
InjuryAug 16, 2026Failure to Osseointegrate
InjuryAug 14, 2026Failure to Osseointegrate
InjuryAug 12, 2026Failure to Osseointegrate
InjuryAug 6, 2026Failure to Osseointegrate
InjuryAug 5, 2026Failure to Osseointegrate
InjuryJul 10, 2026Failure to Osseointegrate
InjuryJul 7, 2026Failure to Osseointegrate
InjuryJun 25, 2026Failure to Osseointegrate
InjuryJun 24, 2026Failure to Osseointegrate
InjuryJun 21, 2026Failure to Osseointegrate
InjuryJun 17, 2026Failure to Osseointegrate
InjuryJun 16, 2026Failure to Osseointegrate
InjuryJun 10, 2026Failure to Osseointegrate
InjuryJun 10, 2026Failure to Osseointegrate
InjuryJun 5, 2026Failure to Osseointegrate
InjuryJun 3, 2026Failure to Osseointegrate
InjuryMay 26, 2026Failure to Osseointegrate
InjuryMay 20, 2026Failure to Osseointegrate
InjuryMay 19, 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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