BioHorizons BTR5212Recalls & reported problems
Biohorizons Implant Systems, Inc · 5.2mm x 12mm Tapered Pro Implant, RBT · Class 2 · Implant
Quick summary
This BioHorizons BTR5212 is a tapered endosseous dental implant used as a tooth root replacement. The 30 reports mostly describe the implant failing to fuse with the surrounding bone, with some cases where it was taken out shortly after surgery. All 30 reports describe injuries, and no deaths were reported. No recalls name this device. Reports in the last 12 months numbered 16, compared with 8 in the previous 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
- 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 00847236021955), received between Feb 28, 2024 and Aug 6, 2026 — classified as 30 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (25 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 Osseointegrate25
- Use of Device Problem6
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 6, 2026Failure to Osseointegrate
InjuryJul 10, 2026Failure to Osseointegrate
InjuryJul 10, 2026Failure to Osseointegrate
InjuryJul 6, 2026Failure to Osseointegrate
InjuryJun 23, 2026Failure to Osseointegrate
InjuryMay 24, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25267187 ↗InjuryMay 22, 2026Failure to Osseointegrate
InjuryApr 30, 2026Failure to Osseointegrate
InjuryApr 27, 2026Failure to Osseointegrate
InjuryMar 22, 2026Failure to Osseointegrate
InjuryMar 16, 2026Failure to Osseointegrate
InjuryDec 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 19, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21646125 ↗InjuryFeb 11, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21354603 ↗InjuryNov 13, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 6, 2024Use of Device Problem; Failure to Osseointegrate; Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 20162064 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.