BioHorizons BTR5209Recalls & reported problems
Biohorizons Implant Systems, Inc · 5.2mm x 9mm Tapered Pro Implant, RBT · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons tapered root-form dental implant is used as an anchor for a replacement tooth. Most of the 69 reports describe the implant not fusing properly with the surrounding bone, so it had to be taken back out shortly after surgery. All 69 reports are injuries, with no deaths. 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
- 70
- Deaths reported
- 0
- Injuries reported
- 70
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00847236021931), received between Feb 24, 2024 and Sep 29, 2026 — classified as 70 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (60 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 Osseointegrate60
- Use of Device Problem13
Patient problems
- Insufficient Information70
Recent adverse event reports
The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Failure to Osseointegrate
InjurySep 29, 2026Failure to Osseointegrate
InjuryAug 14, 2026Failure to Osseointegrate
InjuryJun 8, 2026Failure to Osseointegrate
InjuryMay 20, 2026Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25228674 ↗InjuryApr 30, 2026Failure to Osseointegrate
InjuryApr 23, 2026Failure to Osseointegrate
InjuryApr 11, 2026Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS
Patient problems: Insufficient Information
MAUDE report 24847726 ↗InjuryApr 11, 2026Failure to Osseointegrate
InjuryApr 2, 2026Failure to Osseointegrate
InjuryApr 2, 2026Failure to Osseointegrate
InjuryMar 13, 2026Failure to Osseointegrate
InjuryFeb 24, 2026Failure to Osseointegrate
InjuryFeb 14, 2026Failure to Osseointegrate
InjuryJan 25, 2026Failure to Osseointegrate
InjuryDec 28, 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 23808788 ↗InjuryDec 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 29, 2025Failure to Osseointegrate; Failure 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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