BioHorizons TTLY3010Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Tissue Level Implant, 3.0 x 10.5mm, 3.5 platform · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons tapered tissue-level dental implant is a screw-shaped root-form implant used to anchor a replacement tooth in the jaw. The 45 reports mostly describe the implant failing to fuse with the surrounding bone after placement, with 45 injuries and no deaths. There are no recalls.
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
- 45
- Deaths reported
- 0
- Injuries reported
- 45
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00847236009540), received between Feb 25, 2024 and Jul 9, 2026 — classified as 45 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (36 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate36
- Use of Device Problem10
Patient problems
- Insufficient Information45
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2026Failure to Osseointegrate
InjuryJul 9, 2026Failure to Osseointegrate
InjuryJul 9, 2026Failure to Osseointegrate
InjuryJun 19, 2026Failure to Osseointegrate
InjuryMay 15, 2026Failure to Osseointegrate
InjuryApr 2, 2026Failure to Osseointegrate
InjuryMar 15, 2026Failure to Osseointegrate
InjuryFeb 17, 2026Failure to Osseointegrate
InjuryDec 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 15, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23812228 ↗InjuryAug 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 2, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22382784 ↗InjuryJun 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 21, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22064846 ↗InjuryMay 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 1, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 18, 2025Failure to Osseointegrate; Failure 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 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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