BioHorizons TRXP3810Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Platform Switch Implant, 3.8 x 10.5mm, RBT · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons dental implant is placed in the jaw to replace a tooth root. Reports mostly describe the implant failing to bond with the jawbone. There are 58 reports, including 58 injuries and no deaths, and no recalls name this device. Reports increased from 14 in the previous 12 months to 31 in the latest 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
- 58
- Deaths reported
- 0
- Injuries reported
- 58
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00847236012700), received between Feb 24, 2024 and Sep 21, 2026 — classified as 58 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (53 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 Osseointegrate53
- Use of Device Problem6
- Fracture1
Patient problems
- Insufficient Information58
Recent adverse event reports
The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Failure to Osseointegrate
InjuryJun 25, 2026Failure to Osseointegrate
InjuryJun 3, 2026Fracture; Failure to Osseointegrate
InjuryMay 26, 2026Failure to Osseointegrate
InjuryMay 26, 2026Failure to Osseointegrate
InjuryMay 12, 2026Failure to Osseointegrate
InjuryMay 12, 2026Failure to Osseointegrate
InjuryMay 12, 2026Failure to Osseointegrate
InjuryMay 12, 2026Failure to Osseointegrate
InjuryApr 23, 2026Failure to Osseointegrate
InjuryApr 22, 2026Failure to Osseointegrate
InjuryApr 6, 2026Failure to Osseointegrate
InjuryApr 6, 2026Failure to Osseointegrate
InjuryApr 6, 2026Failure to Osseointegrate
InjuryApr 2, 2026Failure to Osseointegrate
InjuryApr 1, 2026Use of Device Problem; Failure to Osseointegrate
InjuryMar 17, 2026Failure to Osseointegrate
InjuryMar 12, 2026Failure to Osseointegrate
InjuryMar 3, 2026Failure to Osseointegrate
InjuryFeb 26, 2026Failure to Osseointegrate
InjuryFeb 13, 2026Failure to Osseointegrate
InjuryFeb 5, 2026Failure to Osseointegrate
InjuryJan 12, 2026Failure to Osseointegrate
InjuryDec 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 28, 2025Failure 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 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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