BioHorizons TTLG4609Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Tissue Level Implant, 4.6 x 9mm, 4.5 platform · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons TTLG4609 is a small tapered dental implant screw placed in the jawbone to support a replacement tooth. The 38 reports mostly describe the implant failing to fuse with the surrounding bone, so it had to be taken back out, in some cases within a day of placement; all 38 involve injuries and none resulted in death. 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
- 39
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00847236009519), received between Feb 21, 2024 and Sep 14, 2026 — classified as 39 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (24 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 Osseointegrate24
- Use of Device Problem16
- Loss of Osseointegration1
Patient problems
- Insufficient Information39
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Failure to Osseointegrate
InjuryJul 6, 2026Failure to Osseointegrate
InjuryJun 16, 2026Failure to Osseointegrate
InjuryApr 22, 2026Failure to Osseointegrate
InjuryApr 20, 2026Failure to Osseointegrate
InjuryMar 15, 2026Failure to Osseointegrate
InjuryMar 4, 2026Failure to Osseointegrate
InjuryFeb 17, 2026Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24366534 ↗InjuryFeb 17, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24366532 ↗InjuryJan 8, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24003437 ↗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 23930557 ↗InjuryDec 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
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 23256645 ↗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 23256599 ↗InjuryAug 22, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22877430 ↗InjuryAug 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 22, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22568629 ↗InjuryJun 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 5, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21317599 ↗InjuryFeb 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 2, 2024Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 20355363 ↗
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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