BioHorizons TLX3818Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Internal Implant, RBT, Laser-Lok, 3.8 x 18mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons dental implant is placed in the jaw to support replacement teeth. Reports mostly describe the implant not bonding with the bone. There are 25 reports naming its identifier, with no deaths and 25 injuries mentioned. 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
- 25
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00847236011055), received between Apr 2, 2024 and Sep 28, 2026 — classified as 25 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (22 reports).
1 other recall cover devices cleared under the same FDA submission (K143022, 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 Osseointegrate22
- Use of Device Problem3
Patient problems
- Insufficient Information25
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
InjurySep 10, 2026Failure to Osseointegrate
InjuryJun 30, 2026Failure to Osseointegrate
InjuryJun 24, 2026Failure to Osseointegrate
InjuryMar 17, 2026Failure to Osseointegrate
InjuryJan 16, 2026Failure to Osseointegrate
InjuryJan 12, 2026Failure to Osseointegrate
InjuryNov 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 10, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21349781 ↗InjuryFeb 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 28, 2024Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS
Patient problems: Insufficient Information
MAUDE report 20091789 ↗InjuryJul 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 2, 2024Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 19027462 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K143022, 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 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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