BioHorizons BTR5210Recalls & reported problems
Biohorizons Implant Systems, Inc · 5.2mm x 10.5mm Tapered Pro Implant, RBT · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This is a BioHorizons tapered endosseous dental implant used as a root-form replacement for a missing tooth. The 53 adverse event reports mostly describe the implant failing to fuse with the surrounding bone, so it does not become stable and has to be addressed; all53 involve an injury, and no deaths are reported. No recalls name this device. Reports rose from 12 in the previous 12 months to 27 in the most recent 12 months.
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
- 54
- Deaths reported
- 0
- Injuries reported
- 54
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00847236021948), received between Mar 1, 2024 and Sep 30, 2026 — classified as 54 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (43 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 Osseointegrate43
- Use of Device Problem11
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Insufficient Information54
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
InjurySep 8, 2026Failure to Osseointegrate
InjurySep 3, 2026Failure to Osseointegrate
InjuryAug 11, 2026Failure to Osseointegrate
InjuryAug 6, 2026Failure to Osseointegrate
InjuryAug 6, 2026Failure to Osseointegrate
InjuryJul 10, 2026Failure to Osseointegrate
InjuryJun 10, 2026Failure to Osseointegrate
InjuryJun 2, 2026Failure to Osseointegrate
InjuryMay 22, 2026Failure to Osseointegrate
InjuryMay 22, 2026Failure to Osseointegrate
InjuryMay 20, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25228680 ↗InjuryMay 20, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25228670 ↗InjuryMay 15, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS
Patient problems: Insufficient Information
MAUDE report 25182759 ↗InjuryApr 30, 2026Failure to Osseointegrate
InjuryApr 11, 2026Failure to Osseointegrate
InjuryApr 6, 2026Failure to Osseointegrate
InjuryMar 17, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24615909 ↗InjuryMar 12, 2026Manufacturing, Packaging or Shipping Problem
IMPLANT WAS FOUND OUTSIDE THE VIAL.
Patient problems: Insufficient Information
MAUDE report 24579230 ↗InjuryMar 5, 2026Failure to Osseointegrate
InjuryFeb 13, 2026Failure to Osseointegrate
InjuryFeb 5, 2026Failure to Osseointegrate
InjuryJan 26, 2026Failure to Osseointegrate
InjuryDec 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 21, 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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