BioHorizons TLXP4615Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Internal Plus Implant, 4.6mm x 15mm, 3.5 Platform, Laser-Lok · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons Tapered Internal Plus is a dental implant placed in the jawbone. Its 78 reports, with no deaths and 78 injuries, mostly describe implants that failed to bond with the jawbone, and many reports give little detail about the patient. 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
- 79
- Deaths reported
- 0
- Injuries reported
- 79
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00847236009687), received between Feb 25, 2024 and Aug 19, 2026 — classified as 79 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (56 reports).
1 other recall cover devices cleared under the same FDA submission (K121787, 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 Osseointegrate56
- Use of Device Problem27
Patient problems
- Insufficient Information79
Recent adverse event reports
The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.
InjuryAug 19, 2026Failure to Osseointegrate
InjuryAug 18, 2026Failure to Osseointegrate
InjuryAug 7, 2026Failure to Osseointegrate
InjuryAug 7, 2026Failure to Osseointegrate
InjuryAug 6, 2026Failure to Osseointegrate
InjuryJul 12, 2026Failure to Osseointegrate
InjuryJun 24, 2026Failure to Osseointegrate
InjuryMay 22, 2026Failure to Osseointegrate
InjuryMay 12, 2026Failure to Osseointegrate
InjuryMar 18, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24629585 ↗InjuryMar 15, 2026Failure to Osseointegrate
InjuryMar 3, 2026Failure to Osseointegrate
InjuryFeb 25, 2026Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24446623 ↗InjuryFeb 19, 2026Failure to Osseointegrate
InjuryFeb 17, 2026Failure to Osseointegrate
InjuryFeb 6, 2026Failure to Osseointegrate
InjuryJan 13, 2026Failure to Osseointegrate
InjuryJan 9, 2026Failure to Osseointegrate
InjuryDec 16, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23815224 ↗InjuryDec 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 16, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23310266 ↗InjurySep 23, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23128873 ↗InjuryAug 15, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22822017 ↗InjuryAug 15, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22820825 ↗InjuryAug 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
Recalls under the same FDA submission
These recalls involve devices cleared under K121787, 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 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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