BioHorizons TMR4610Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Internal Implant RBT 4.6 x 10.5mm, 4.5 Platform · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons dental implant has 200 adverse event reports, with no deaths and 200 injuries. Most reports describe the implant failing to bond with the jawbone. Reports dropped to 61 in the last 12 months from 75 in the 12 months before. There are no recalls that 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
- 201
- Deaths reported
- 0
- Injuries reported
- 201
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 201 adverse event reports that list this exact device (DI 00847236010324), received between Feb 15, 2024 and Sep 8, 2026 — classified as 201 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (186 reports).
2 other recalls cover devices cleared under the same FDA submission (K071638, 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 Osseointegrate186
- Use of Device Problem15
- Fracture4
- Loss of Osseointegration1
- Osseointegration Problem1
Patient problems
- Insufficient Information201
Recent adverse event reports
The 25 most recent of 201 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50679453 ↗InjuryAug 16, 2026Failure to Osseointegrate
InjuryAug 16, 2026Failure to Osseointegrate
InjuryAug 14, 2026Failure to Osseointegrate
InjuryAug 14, 2026Failure to Osseointegrate
InjuryAug 14, 2026Failure to Osseointegrate
InjuryAug 14, 2026Failure to Osseointegrate
InjuryAug 14, 2026Failure to Osseointegrate
InjuryAug 14, 2026Failure to Osseointegrate
InjuryAug 11, 2026Failure to Osseointegrate
InjuryJul 12, 2026Failure to Osseointegrate
InjuryJul 12, 2026Failure to Osseointegrate
InjuryJul 7, 2026Failure to Osseointegrate
InjuryJun 30, 2026Failure to Osseointegrate
InjuryJun 26, 2026Failure to Osseointegrate
InjuryJun 17, 2026Failure to Osseointegrate
InjuryJun 16, 2026Failure to Osseointegrate
InjuryMay 26, 2026Failure to Osseointegrate
InjuryMay 26, 2026Failure to Osseointegrate
InjuryMay 20, 2026Failure to Osseointegrate
InjuryMay 12, 2026Failure to Osseointegrate
InjuryMay 4, 2026Failure to Osseointegrate
InjuryApr 29, 2026Failure to Osseointegrate
InjuryApr 27, 2026Failure to Osseointegrate
InjuryApr 27, 2026Failure to Osseointegrate
Recalls under the same FDA submission
These recalls involve devices cleared under K071638, 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
- Z-1605-2015 · Apr 16, 2015 · TerminatedTapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
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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