BioHorizons BTR4612Recalls & reported problems
Biohorizons Implant Systems, Inc · 4.6mm x 12mm Tapered Pro Implant, RBT · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons Tapered Pro dental implant is placed in the jawbone to support a replacement tooth. Most of its 103 reports describe the implant failing to bond with the jawbone, and some describe implants removed soon after placement. The reports mention no deaths and 103 injuries. Reports rose to 47 in the last 12 months, from 25 in the 12 months before. 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
- 104
- Deaths reported
- 0
- Injuries reported
- 104
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 00847236021900), received between Mar 21, 2024 and Sep 30, 2026 — classified as 104 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (89 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 Osseointegrate89
- Use of Device Problem18
- Osseointegration Problem4
Patient problems
- Insufficient Information104
Recent adverse event reports
The 25 most recent of 104 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
InjurySep 29, 2026Failure to Osseointegrate
InjurySep 21, 2026Failure to Osseointegrate
InjurySep 17, 2026Failure to Osseointegrate
InjuryAug 12, 2026Failure to Osseointegrate
InjuryAug 12, 2026Failure to Osseointegrate
InjuryJul 16, 2026Failure to Osseointegrate
InjuryJul 10, 2026Failure to Osseointegrate
InjuryJul 10, 2026Failure to Osseointegrate
InjuryJul 10, 2026Failure to Osseointegrate
InjuryJul 10, 2026Failure to Osseointegrate
InjuryJun 16, 2026Failure to Osseointegrate
InjuryJun 8, 2026Failure to Osseointegrate
InjuryJun 1, 2026Failure to Osseointegrate
InjuryMay 26, 2026Failure to Osseointegrate
InjuryMay 21, 2026Failure to Osseointegrate
InjuryMay 5, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25085679 ↗InjuryMay 1, 2026Failure to Osseointegrate
InjuryApr 28, 2026Failure to Osseointegrate
InjuryApr 23, 2026Failure to Osseointegrate
InjuryApr 17, 2026Failure to Osseointegrate
InjuryApr 8, 2026Failure to Osseointegrate
InjuryApr 6, 2026Failure to Osseointegrate
InjuryApr 6, 2026Failure to Osseointegrate
InjuryApr 6, 2026Failure to Osseointegrate
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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