BioHorizons BTA4618Recalls & reported problems
Biohorizons Implant Systems, Inc · 4.6 x 18mm Tapered Pro Implant, Laser-Lok, RBT · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons BTA4618 tapered dental implant is a root-form implant used to replace a tooth. The 30 reports mostly describe the implant failing to fuse with the surrounding bone, with several noting it had to be taken out shortly after placement. There are no deaths, and 30 injuries. 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
- 30
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00847236013790), received between Feb 21, 2024 and Aug 28, 2026 — classified as 30 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (19 reports).
2 other recalls cover devices cleared under the same FDA submission (K071638, 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate19
- Use of Device Problem12
- Osseointegration Problem1
Patient problems
- Insufficient Information30
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2026Failure to Osseointegrate
InjuryJul 21, 2026Failure to Osseointegrate
InjuryJun 2, 2026Failure to Osseointegrate
InjuryJun 2, 2026Failure to Osseointegrate
InjuryJun 2, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25363645 ↗InjuryApr 9, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS
Patient problems: Insufficient Information
MAUDE report 24830205 ↗InjuryApr 8, 2026Use of Device Problem; Failure to Osseointegrate
InjuryApr 8, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24816327 ↗InjuryMar 13, 2026Failure to Osseointegrate
InjuryMar 10, 2026Failure to Osseointegrate
InjuryMar 10, 2026Failure to Osseointegrate
InjuryMar 10, 2026Failure to Osseointegrate
InjuryAug 7, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22740268 ↗InjuryJul 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 13, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22013286 ↗InjuryApr 3, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21767120 ↗InjuryApr 1, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 1, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 29, 2024Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 19852719 ↗InjuryJul 29, 2024Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 19851134 ↗InjuryJul 10, 2024Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 19709742 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K071638, 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
- 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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