BioHorizons TTLG4610Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Tissue Level Implant, 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 TTLG4610 is a tapered, tissue-level dental implant screw used to anchor a replacement tooth in the jawbone. Most of the 50 reports describe the implant failing to fuse with the surrounding bone, so it does not become stable and the site has to be redone; the reports list 50 injuries and no deaths. No recalls name this device. In the past 12 months there were 23 reports, up from 12 in the 12 months before that.
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
- 50
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00847236009526), received between Mar 6, 2024 and Aug 12, 2026 — classified as 50 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (27 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 Osseointegrate27
- Use of Device Problem23
Patient problems
- Insufficient Information50
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2026Failure to Osseointegrate
InjuryAug 3, 2026Failure to Osseointegrate
InjuryJun 3, 2026Failure to Osseointegrate
InjuryMay 29, 2026Failure to Osseointegrate
InjuryMay 29, 2026Failure to Osseointegrate
InjuryMay 29, 2026Failure to Osseointegrate
InjuryMay 29, 2026Failure to Osseointegrate
InjuryMay 29, 2026Failure to Osseointegrate
InjuryMay 15, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25182831 ↗InjuryMay 15, 2026Failure to Osseointegrate
InjuryApr 23, 2026Failure to Osseointegrate
InjuryApr 22, 2026Failure to Osseointegrate
InjuryApr 7, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24803819 ↗InjuryApr 2, 2026Failure to Osseointegrate
InjuryMar 17, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24616503 ↗InjuryFeb 17, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24367511 ↗InjuryFeb 17, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24367498 ↗InjuryFeb 17, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24367489 ↗InjuryFeb 17, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24366524 ↗InjuryJan 28, 2026Failure to Osseointegrate
InjuryJan 8, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24003297 ↗InjuryDec 30, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23930596 ↗InjuryDec 10, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23774137 ↗InjuryOct 9, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23256570 ↗InjuryJul 29, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22649126 ↗
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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